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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02624986
Registration number
NCT02624986
Ethics application status
Date submitted
1/12/2015
Date registered
9/12/2015
Date last updated
18/05/2020
Titles & IDs
Public title
A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants
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Scientific title
A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Idasanutlin in Patients With Relapsed or Refractory Follicular Lymphoma and Obinutuzumab or Rituximab in Combination With Idasanutlin in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
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Secondary ID [1]
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2015-002100-83
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Secondary ID [2]
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BH29812
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Idasanutlin
Treatment: Drugs - Obinutuzumab
Treatment: Drugs - Rituximab
Experimental: DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg - Participants with diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Experimental: DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg - Participants with diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
Experimental: DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg - Participants with diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
Experimental: DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 - Participants with diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).
Experimental: DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 - Participants with diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).
Experimental: FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg - Participants with follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Experimental: FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg - Participants with follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).
Experimental: FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg - Participants with follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).
Treatment: Drugs: Idasanutlin
Participants received idasanutlin film-coated tablets orally at a starting dose of 100 mg daily on Days 1 to 5 of each 28-day cycle. Escalation was to occur in at least 50-mg increments, and daily doses greater than or equal to (=) 400 mg will be split into twice daily dosing.
Treatment: Drugs: Obinutuzumab
Participants received a fixed dose of obinutuzumab 1000 mg intravenous (IV) infusion to be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 (1 cycle = 28 days). For eligible participants with FL, post-induction treatment was to be given at a dose of 1000 mg via IV infusion on Day 1 once every 2 months for a maximum of up to 24 months.
Treatment: Drugs: Rituximab
Participants received a fixed dose of rituximab, 375 mg/m\^2 IV infusion on Day 1 of Cycles 1-6. Post-induction treatment for eligible participants was to be given at a dose of 375 mg/m\^2 IV infusion on Day 1 of every other month for up to 6 months, until disease progression or unacceptable toxicity.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Complete Response at the End of Induction, Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scans Using Modified Lugano 2014 Criteria
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Assessment method [1]
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The plan was for the IRC to evaluate responses at the end of induction treatment in participants from the expansion phase using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[=\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and = liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if indeterminate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.
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Timepoint [1]
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Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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Secondary outcome [1]
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Number of Participants With a Dose-Limiting Toxicity
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Assessment method [1]
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A dose-limiting toxicity (DLT) was defined as at least one of the following events occurring during Cycle 1 (or first 2 cycles in the bridging FL cohort) of treatment and assessed by the investigator as not clearly related to the underlying disease: Any Grade 5 adverse event (AE; severity graded per NCI-CTCAE v4.0) unless due to the underlying malignancy or extraneous causes; AE of any grade that leads to a delay of more than (\>)14 days in the start of the next treatment cycle; Grade 3 or 4 non-hematologic AEs (with exceptions); Lab results suggestive of potential drug-induced liver injury (according to Hy's law); Grade 3 or 4 neutropenia in the presence of sustained fever of \>38 C (lasting \>5 days) or a documented infection; Grade 4 neutropenia or thrombocytopenia lasting \>7 days; Grade 3 or 4 thrombocytopenia if associated with Grade =3 bleeding; Other toxicities considered clinically relevant and related to study treatment as determined by the investigator and medical monitor.
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Timepoint [1]
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Cycles 1, 2 (1 cycle is 28 days)
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Secondary outcome [2]
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Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria
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Assessment method [2]
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The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[=\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and = liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if indeterminate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders.
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Timepoint [2]
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Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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Secondary outcome [3]
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Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria
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Assessment method [3]
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The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[=\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and = liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma). The CR criteria for participants with bone marrow involvement at screening required no evidence of FDG-avid disease in the marrow. PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders.
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Timepoint [3]
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Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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Secondary outcome [4]
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Percentage of Participants With Complete Response at the End of Induction, Determined by the IRC on the Basis of CT Scans Alone Using Lugano 2014 Criteria
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Assessment method [4]
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The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimetres in the longest transverse diameter of a lesion \[LDi\]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.
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Timepoint [4]
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Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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Secondary outcome [5]
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Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria
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Assessment method [5]
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0
The investigator evaluated responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimetres in the longest transverse diameter of a lesion \[LDi\]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.
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Timepoint [5]
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Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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Secondary outcome [6]
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Percentage of Participants With Objective Response at the End of Induction, Determined by the IRC on the Basis of PET-CT Scans Using Lugano 2014 Criteria
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Assessment method [6]
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The IRC was to evaluate responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 \[no uptake above background\] to 5 \[uptake markedly higher than liver and/or new lesions\]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders.
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Timepoint [6]
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0
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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Secondary outcome [7]
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0
Percentage of Participants With Objective Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria
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Assessment method [7]
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0
The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 \[no uptake above background\] to 5 \[uptake markedly higher than liver and/or new lesions\]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders.
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Timepoint [7]
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Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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Secondary outcome [8]
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0
Percentage of Participants With Objective Response at the End of Induction, Determined by an IRC on the Basis of CT Scans Alone Using Lugano 2014 Criteria
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Assessment method [8]
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0
The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a =50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.
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Timepoint [8]
0
0
Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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Secondary outcome [9]
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0
Percentage of Participants With Objective Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria
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Assessment method [9]
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The investigator was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a =50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.
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Timepoint [9]
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Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)
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Secondary outcome [10]
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Percentage of Participants With Best Response of Complete Response or Partial Response During the Study, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria
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Assessment method [10]
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The investigator was to evaluate responses throughout the study using the Lugano 2014 response criteria for malignant lymphoma for a CT-based best response of a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a =50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.
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Timepoint [10]
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Baseline, Cycle 2, end of induction (up to 6 cycles; 1 cycle is 28 days), every 2 months (FL) until end of maintenance or at 4 months (DLBCL) of consolidation treatment, and then every 6 months during follow-up until disease progression (up to 3.5 years)
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Secondary outcome [11]
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Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab)
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Assessment method [11]
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The concentration of idasanutlin was determined using a validated assay. The duplication of the predose timepoint (0 hours) on Day 5 as an additional 24-hour timepoint on Day 5 was done in order to conduct pharmacokinetics analysis via non-compartmental analysis, and to derive idasanutlin exposure estimates up to the 24-hour post Day 5 dosing.
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Timepoint [11]
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Predose (0 hours) and 6 hours postdose on Day 1 of Cycles 1, 2, and 4; Predose (0 hours) and 2, 4, 6, and 24 hours postdose on Day 5 of Cycles 1 and 2; Predose (0 hours) and 6 and 24 hours postdose on Cycle 4, Day 5 (1 cycle is 28 days)
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Secondary outcome [12]
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0
Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints
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Assessment method [12]
0
0
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Timepoint [12]
0
0
Pre-infusion (0 hour) and 0.5 hours after end of obinutuzumab infusion on Day 1 of Cycles 1, 2, 4, and 6
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Secondary outcome [13]
0
0
Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints
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Assessment method [13]
0
0
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Timepoint [13]
0
0
Pre-infusion (0 hours) at Cycle 1, Day 1 and Cycle 2, Day 1; Post-infusion 0.5 hours at Cycle 1, Day 1 (1 cycle is 28 days)
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Secondary outcome [14]
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Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)
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Assessment method [14]
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The adverse event (AE) severity grading scale for the NCI CTCAE v4.0 was used for assessing AE severity. Any AEs that were not specifically listed in the NCI CTCAE, v4.0 were graded per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.
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Timepoint [14]
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From first dose until 90 days after the last dose of study drug treatment (up to 31 months)
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Secondary outcome [15]
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0
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints
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Assessment method [15]
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Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance
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Timepoint [15]
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Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months)
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Secondary outcome [16]
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Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints
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Assessment method [16]
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Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance
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Timepoint [16]
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Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months)
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Secondary outcome [17]
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0
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints
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Assessment method [17]
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Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance
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Timepoint [17]
0
0
Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months)
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Secondary outcome [18]
0
0
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints
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Assessment method [18]
0
0
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance
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Timepoint [18]
0
0
Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months)
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Secondary outcome [19]
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0
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints
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Assessment method [19]
0
0
Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance
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Timepoint [19]
0
0
Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months)
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Secondary outcome [20]
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0
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints
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Assessment method [20]
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Single, resting, 12-lead ECG recordings were to be obtained after the participant had been resting in a supine position for at least 10 minutes. Any morphologic waveform changes or other ECG abnormalities were to be documented and clinical significance was determined based on the presence of symptoms, per the investigator's judgment. If the ECG assessment was missing at baseline then it was recorded as "Missing". The ECG results assessments are presented as the shift from baseline to post-baseline assessments at each timepoint. BL = baseline; Cyc1, D1 = Induction Cycle 1 Day 1; Cyc4, D1 = Induction Cycle 4 Day 1; CS = Clinically Significant; EOI = End of Induction Treatment - Completion/Discontinuation; EOM = End of Maintenance Treatment - Completion/Discontinuation; MM1 = Maintenance Month 1; Unsched = Unscheduled Visit
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Timepoint [20]
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Baseline, Induction Cycle 1 Day 1 and Cycle 4 Day 1, End of Induction (up to 6 cycles; 1 cycle is 28 days); Every 2 months during maintenance treatment from Months 1-23; End of Maintenance (up to 24 months); Unscheduled Visits (as clinically indicated)
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Secondary outcome [21]
0
0
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline
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Assessment method [21]
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0
Clinical laboratory tests for hematology parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) at baseline to the highest grade post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a patient with multiple post-baseline abnormalities, the highest (worst) grade for a given lab test is reported. Abs. = absolute count; BL = baseline; WBC = white blood cell count
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Timepoint [21]
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0
From Baseline until 35 days after the last dose of study drug (up to 29 months)
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Secondary outcome [22]
0
0
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline
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Assessment method [22]
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0
Clinical laboratory tests for blood chemistry parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) at baseline to the highest grade post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a patient with multiple post-baseline abnormalities, the highest (worst) grade for a given lab test is reported. BL = Baseline; Blood Gluc., Fast. = blood glucose, fasting; SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase; SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase; Triacylglyc. Lipase = triacylglycerol lipase
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Timepoint [22]
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From Baseline until 35 days after the last dose of study drug (up to 29 months)
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Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Histologically documented cluster of differentiation (CD) 20-positive B-cell lymphoma classified as relapsed or refractory FL or DLBCL after treatment with at least two prior chemoimmunotherapy regimens that included an anti-CD20 monoclonal antibody (mAb) and for which no other more appropriate treatment option exists
* At least one bidimensionally measurable lesion
* Agreement to remain abstinent or use adequate contraception, among women or men of childbearing potential
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Known CD20-negative status at relapse or progression
* Prior allogeneic stem cell transplantation (SCT), or autologous SCT within 100 days prior to Day 1 of Cycle 1
* Current use of systemic corticosteroids greater than (>) 20 mg prednisone per day (or equivalent), or prior anti-cancer therapy to include: radioimmunoconjugate within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
* Requirement for chronic anticoagulation
* Central nervous system (CNS) disease
* Active infection
* Positive for human immunodeficiency virus (HIV) or hepatitis B or C
* Receipt of a live virus vaccine within 28 days prior to Day 1 of Cycle 1
* Poor hematologic, renal, or hepatic function
* Pregnant or lactating women
* History of progressive multifocal leukoencephalopathy (PML)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/12/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/05/2019
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Sample size
Target
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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0
Prince of Wales Hospital - Randwick
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Recruitment hospital [2]
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0
Westmead Hospital - Westmead
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Recruitment hospital [3]
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0
Linear Clinical Research Limited - Nedlands
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Kentucky
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Country [4]
0
0
United States of America
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State/province [4]
0
0
North Carolina
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Pennsylvania
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Rhode Island
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Virginia
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Country [8]
0
0
Germany
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State/province [8]
0
0
Augsburg
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Country [9]
0
0
Germany
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State/province [9]
0
0
Berlin
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Country [10]
0
0
Germany
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State/province [10]
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0
Heilbronn
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Country [11]
0
0
Germany
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State/province [11]
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Köln
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Country [12]
0
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Germany
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State/province [12]
0
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Würzburg
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Country [13]
0
0
Korea, Republic of
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State/province [13]
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Daegu
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Country [14]
0
0
Korea, Republic of
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State/province [14]
0
0
Gyeonggi-do
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Country [15]
0
0
Korea, Republic of
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State/province [15]
0
0
Seoul
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Country [16]
0
0
New Zealand
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State/province [16]
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0
Auckland
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Country [17]
0
0
New Zealand
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State/province [17]
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Christchurch
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Country [18]
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New Zealand
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State/province [18]
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0
Grafton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a open-label, multicenter, non-randomized, study to evaluate the safety, efficacy, and pharmacokinetics of idasanutlin in combination with obinutuzumab in participants with R/R FL and rituximab in combination with idasanutlin in R/R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase 2 dose (RP2D) for idasanutlin in combination with obinutuzumab for FL and in combination with rituximab for DLBCL. The expansion phase is designed to further assess the safety and efficacy of obinutuzumab in combination with idasanutlin at the RP2D with the selected regimen in participants with R/R FL and of rituximab in combination with idasanutlin at the RP2D in participants with R/R DLBCL.
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Trial website
https://clinicaltrials.gov/study/NCT02624986
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
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Clinical Trials
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Address
0
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Hoffmann-La Roche
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Country
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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Address
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0
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Country
0
0
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Phone
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/86/NCT02624986/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/86/NCT02624986/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02624986
Download to PDF