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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02055820
Registration number
NCT02055820
Ethics application status
Date submitted
4/02/2014
Date registered
5/02/2014
Date last updated
11/06/2020
Titles & IDs
Public title
A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL
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Scientific title
A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL
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Secondary ID [1]
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2013-003749-40
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Secondary ID [2]
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GO27878
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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:
Lymphoma, Non-Hodgkin
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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 - Venetoclax
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Obinutuzumab
Treatment: Drugs - Rituximab
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone
Experimental: Venetoclax + G-CHOP Arm - Phase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + obinutuzumab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + obinutuzumab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Experimental: Venetoclax + R-CHOP Arm - Phase I: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax + rituximab. Each cycle will consist of 21 days. Phase II: Participants will receive 6 cycles of CHOP and 8 cycles of venetoclax (at dose determined in Phase I) + rituximab. Each cycle will consist of 21 days. For both phase I and II, participants with ongoing response without excessive toxicity may receive up to eight cycles of CHOP following discussion between the investigator and the Medical Monitor.
Treatment: Drugs: Venetoclax
Venetoclax 200 to 800 milligrams (mg) tablets will be administered orally once daily (QD) on Days 4-10 of Cycle 1 and Days 1-10 of Cycles 2-8 during Phase I and MTD will be administered according to the same schedule during Phase II.
Treatment: Drugs: Cyclophosphamide
Cyclophosphamide 750 milligrams per square meter (mg/m^2) administered intravenously (IV) on Day 1 of each 21-day cycle up to Cycle 6.
Treatment: Drugs: Obinutuzumab
Obinutuzumab will be administered by IV infusion as an absolute dose of 1000 mg on Days 1, 8, 15 of Cycle 1 and Day 1 of Cycles 2-8 (cycle length = 21 days).
Treatment: Drugs: Rituximab
Rituximab 375 mg/m^2 dose will be administered IV on Day 1 of every 21-day cycle.
Treatment: Drugs: Doxorubicin
Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.
Treatment: Drugs: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.
Treatment: Drugs: Prednisone
Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.
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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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Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)
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Assessment method [1]
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DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade >/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs.
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Timepoint [1]
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Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)
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Primary outcome [2]
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Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)
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Assessment method [2]
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CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake </= mediastinum; 3) uptake < mediastinum but </= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy
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Timepoint [2]
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Baseline up to end of treatment (up to approximately 6 months)
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Primary outcome [3]
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Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC
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Assessment method [3]
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CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake </= mediastinum; 3) uptake < mediastinum but </= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.
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Timepoint [3]
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Baseline up to end of treatment (up to approximately 6 months)
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Secondary outcome [1]
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Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)
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Assessment method [1]
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AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
Data are reported as hour*micrograms per milliliter (hr*mcg/mL)
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Timepoint [1]
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Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)
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Secondary outcome [2]
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Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)
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Assessment method [2]
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Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
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Timepoint [2]
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Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
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Secondary outcome [3]
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Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)
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Assessment method [3]
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Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
Data are reported as micrograms per milliliter
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Timepoint [3]
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Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
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Secondary outcome [4]
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Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval
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Assessment method [4]
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Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.
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Timepoint [4]
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Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)
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Secondary outcome [5]
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Prednisone Plasma PK: AUC
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Assessment method [5]
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AUC was determined based on measurement of Predisone concentrations in plasma over time.
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Timepoint [5]
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Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
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Secondary outcome [6]
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Prednisone Plasma PK: Tmax
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Assessment method [6]
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Tmax was determined based on measurement of Predisone concentrations in plasma over time.
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Timepoint [6]
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Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
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Secondary outcome [7]
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Prednisone Plasma PK: Cmax
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Assessment method [7]
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Cmax was determined based on measurement of Predisone concentrations in plasma over time.
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Timepoint [7]
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Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)
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Secondary outcome [8]
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Rituximab PK: Cmax
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Assessment method [8]
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Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.
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Timepoint [8]
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End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Secondary outcome [9]
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Rituximab PK: Cmin Within the Dosing Interval
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Assessment method [9]
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Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2.
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Timepoint [9]
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Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)
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Secondary outcome [10]
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Obinutuzumab PK: Cmax
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Assessment method [10]
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Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.
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Timepoint [10]
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End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Secondary outcome [11]
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Cyclophosphamide PK: Cmax
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Assessment method [11]
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Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1.
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Timepoint [11]
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End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Secondary outcome [12]
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Doxorubicin PK: Cmax
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Assessment method [12]
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Cmax was determined using the post-dose Doxorubicin plasma concentrations.
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Timepoint [12]
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End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Secondary outcome [13]
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Vincristine PK: Cmax
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Assessment method [13]
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Cmax was determined using the post-dose Vincristine plasma concentrations.
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Timepoint [13]
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End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)
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Secondary outcome [14]
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Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC
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Assessment method [14]
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Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.
CR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.
PR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR
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Timepoint [14]
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Baseline to end of treatment (up to approximately 6 months)
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Secondary outcome [15]
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Percentage of Participants Who Are Alive and Without Disease Progression at Month 12
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Assessment method [15]
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Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: >/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions.
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Timepoint [15]
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Month 12
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Secondary outcome [16]
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Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification
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Assessment method [16]
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CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to </= 1.5 cm in longest transverse diameter of a lesion (LDi), no extra-lymphatic sites of disease, absence of non-measured lesions, organ enlargement must have regressed to normal, no new lesions, and if the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.
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Timepoint [16]
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Baseline up to end of treatment (approx. 6 months)
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Secondary outcome [17]
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Safety: Percentage of Participants With Adverse Events
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Assessment method [17]
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An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
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Timepoint [17]
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Baseline up to approximately 36 months
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Secondary outcome [18]
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Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy
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Assessment method [18]
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Maintenance of relative dose intensity was defined as a dose intensity of >/= 90%.
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Timepoint [18]
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Baseline up to Cycle 6 (cycle length = 21 days)
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Secondary outcome [19]
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Relative Dose Intensity of Venetoclax
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Assessment method [19]
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Dose intensity was categorized as < 80%, 80% to < 85%, 85% to < 90%, or >/= 90%.
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Timepoint [19]
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Baseline up to Cycle 6 (cycle length = 21 days)
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Eligibility
Key inclusion criteria
General
- At least one bi-dimensionally measurable lymphoma lesion on CT scan defined as > 1.5
cm in its longest dimension, which is also FDG avid by screening PET scan.
- Confirmed availability of archival or freshly biopsied tumor tissue prior to study
enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Adequate hematologic function
- For female participants of childbearing potential, agreement to use highly effective
forms of contraception
Dose-Escalation Portion of the Study:
- Participants must have histologically confirmed B-cell NHL, except MCL or SLL
- Participants must have never received previous R-CHOP treatment
- Any relapsed/refractory participants that are enrolled during the dose escalation
should have received only a single previous treatment regimen
Expansion Portion of the Study:
- Participants must have previously untreated CD20-positive DLBCL and IPI score must be
2-5
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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
General
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies or known sensitivity or allergy to murine products
- Contraindication to receive any of the individual components of CHOP, rituximab or
obinutuzumab
- Prior anthracycline therapy
- Participants with ongoing corticosteroid use >30 mg per day of prednisone or
equivalent
- CNS lymphoma or primary mediastinal DLBCL
- Vaccination with live vaccines within 28 days prior to randomization
- Chemotherapy or other investigational therapy within 28 days prior to the start of
Cycle 1
- History of other malignancy that could affect compliance with the protocol or
interpretation of results
- Evidence of significant, uncontrolled concomitant disease
- Significant cardiovascular disease or significant pulmonary disease
- Left ventricular ejection fraction less than (<) 50% as defined by multiple-gated
acquisition (MUGA)
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
(excluding fungal infections of nail beds) at study enrollment, or any major episode
of infection requiring treatment with IV antibiotics or hospitalization (relating to
the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1
- Received the following agents within 7 days prior to the first dose of venetoclax:
steroid therapy for anti-neoplastic intent; strong and moderate cytochrome P450 (CYP)
3A4 inhibitors or inducers; grapefruit/grapefruit products, seville oranges or star
fruit within 3 days prior to the first dose of venetoclax
- Clinically significant history of liver disease, including viral or other hepatitis,
current alcohol abuse, or cirrhosis
- Recent major surgery
- Women who are pregnant or lactating
Dose-Escalation Portion of the Study:
- Participants with confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma
(SLL)
Expansion Portion of the Study:
- Participants with transformed lymphoma (participants with discordant bone marrow
involvement (i.e., low grade histology in bone marrow) may be considered after
discussion with the Medical Monitor)
- Prior therapy for NHL
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
17/11/2013
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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
28/06/2019
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Sample size
Target
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Accrual to date
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Final
267
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre-East Melbourne - Melbourne
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Recruitment hospital [4]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment postcode(s) [4]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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Tennessee
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Austria
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Salzburg
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Austria
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State/province [8]
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Wien
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Quebec
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Ostrava - Poruba
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Czechia
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Praha 2
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France
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Creteil
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France
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La Roche sur Yon
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France
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Le Mans
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France
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Lille
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France
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Montpellier
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France
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Nantes
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France
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Paris
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France
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Pierre-Benite
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France
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Rennes cedex 09
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France
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Rouen
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France
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Vandoeuvre-les-nancy
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Hungary
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Budapest
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Hungary
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Debrecen
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Italy
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Campania
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Italy
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Liguria
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Italy
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Piemonte
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Italy
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Sicilia
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Italy
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Toscana
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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State/province [39]
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Salamanca
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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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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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AbbVie
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Address [1]
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Summary
Brief summary
This is a multicenter, open-label, dose-finding study of venetoclax administered orally in
combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide,
doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's
Lymphoma (NHL). The study consisted of 2 stages: a dose-finding Phase Ib stage and a Phase II
expansion stage. In the Phase I portion of the study, participants were randomized to one of
2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in combination
with G-CHOP (Arm B) and explored the doses of venetoclax in combination with R-CHOP and
G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP and G-CHOP
was determined during the dose-finding stage. For the Phase II portion of the study, the
venetoclax dose for venetoclax + R-CHOP was on a non-continuous dosing schedule as determined
by the Phase Ib portion of the study based on safety and tolerability observed in
participants treated in the dose escalation portion of the study. On 17 July 2016,
Roche/Genentech as the sponsor of Study BO21005 (Goya study), a Phase III study that
evaluated G CHOP versus R-CHOP in 1L DLBCL, informed through a press release that the primary
endpoint of investigator-assessed PFS was not met. Given these results, Arm B (venetoclax +
G-CHOP) was not expanded in Phase II in patients who are first-line with DLBCL.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02055820
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Contacts
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02055820
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