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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01200758
Registration number
NCT01200758
Ethics application status
Date submitted
10/09/2010
Date registered
14/09/2010
Date last updated
27/11/2018
Titles & IDs
Public title
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
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Scientific title
A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV
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Secondary ID [1]
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2010-021377-36
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Secondary ID [2]
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BO22334
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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 - Rituximab SC
Treatment: Drugs - Rituximab IV
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone/Prednisolone
Active comparator: Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) - Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or cyclophosphamide, vincristine, prednisolone (CVP) chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
Experimental: Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) - First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
Treatment: Drugs: Rituximab SC
First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
Treatment: Drugs: Rituximab IV
Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
Treatment: Drugs: Cyclophosphamide
Eight cycles of cyclophosphamide (750 mg/m\^2 IV) administered every 3 weeks.
Treatment: Drugs: Doxorubicin
Eight cycles of doxorubicin (50 mg/m\^2 IV) administered every 3 weeks.
Treatment: Drugs: Vincristine
Eight cycles of doxorubicin (1.4 mg/m\^2 IV) administered every 3 weeks.
Treatment: Drugs: Prednisone/Prednisolone
Eight cycles of prednisone/prednisolone (100 mg/day or 40 mg/m\^2/day IV/orally) administered Days 1 to 5 of every 21 days cycle.
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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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Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab
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Assessment method [1]
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Timepoint [1]
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Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)
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Primary outcome [2]
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Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL)
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Assessment method [2]
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Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by more than (\>) 75% in the sum of the products of greatest diameters (SPD); PR: Greater than or equal to (=) 50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.
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Timepoint [2]
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Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
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Secondary outcome [1]
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Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
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Assessment method [1]
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Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in the SPD; PR: =50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.
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Timepoint [1]
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Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
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Secondary outcome [2]
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Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
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Assessment method [2]
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Overall Response comprised of CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD; PR: =50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
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Timepoint [2]
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Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
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Secondary outcome [3]
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Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
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Assessment method [3]
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Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
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Timepoint [3]
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Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
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Secondary outcome [4]
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Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
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Assessment method [4]
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Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
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Timepoint [4]
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Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
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Secondary outcome [5]
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Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
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Assessment method [5]
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Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
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Timepoint [5]
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Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
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Secondary outcome [6]
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Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
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Assessment method [6]
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Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
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Timepoint [6]
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Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
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Secondary outcome [7]
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Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
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Assessment method [7]
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Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
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Timepoint [7]
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Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
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Secondary outcome [8]
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Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death
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Assessment method [8]
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Disease progression: =50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or =50% increase in the greatest diameter of any previously identified node \>1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
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Timepoint [8]
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Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
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Secondary outcome [9]
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Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL
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Assessment method [9]
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PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression: =50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or =50% increase in the greatest diameter of any previously identified node \>1 cm in its short axis or in the SPD of more than one node. PFS analysis was performed using Kaplan - Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
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Timepoint [9]
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Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
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Secondary outcome [10]
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Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL
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Assessment method [10]
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Disease progression: =50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or =50% increase in the greatest diameter of any previously identified node \>1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
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Timepoint [10]
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Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
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Secondary outcome [11]
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Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL
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Assessment method [11]
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Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
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Timepoint [11]
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Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
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Secondary outcome [12]
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Percentage of Participants Who Died
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Assessment method [12]
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Timepoint [12]
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Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
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Secondary outcome [13]
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Overall Survival (OS)
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Assessment method [13]
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OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive.
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Timepoint [13]
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Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
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Secondary outcome [14]
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Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab
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Assessment method [14]
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AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 \[up to 26 months\])
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Timepoint [14]
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Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
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Secondary outcome [15]
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Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab
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Assessment method [15]
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Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 \[up to 26 months\])
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Timepoint [15]
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Stage I (Induction): Predose (within 2hr) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
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Secondary outcome [16]
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Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle
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Assessment method [16]
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Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks \& 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 \& Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 \[up to 32 months\])
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Timepoint [16]
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Stage I and II (Pooled): Predose (within 2hr) up to data cutoff of 31 Oct 2013 [up to 32 months]) (See detailed timeframe in Outcome Measure description)
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Secondary outcome [17]
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Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle
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Assessment method [17]
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Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 \[1 Cy=8 weeks\]; up to data cutoff of 11 Jan 2016 \[up to 6 years\])
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Timepoint [17]
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Stage I and II (maintenance): Predose (within 2hr) up to data cutoff of 11 Jan 2016 [up to 6 years]) (See detailed timeframe in Outcome Measure description)
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Secondary outcome [18]
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Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration
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Assessment method [18]
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Timepoint [18]
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12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])
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Secondary outcome [19]
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Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase
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Assessment method [19]
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Depletion is defined as a cluster of differentiation (CD) 19 value \<80 cells per cubic millimeter (cells/mm\^3).
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Timepoint [19]
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Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2
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Secondary outcome [20]
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Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase
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Assessment method [20]
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Depletion is defined as a CD19 value \<80 cells/mm\^3.
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Timepoint [20]
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Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 11 Jan 2016 [up to 6 years])
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Secondary outcome [21]
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Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab
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Assessment method [21]
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Levels of HACA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 \[up to 6 years\])
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Timepoint [21]
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Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
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Secondary outcome [22]
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Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab
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Assessment method [22]
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Levels of HAHA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 \[up to 6 years\])
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Timepoint [22]
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Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)
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Secondary outcome [23]
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Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20
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Assessment method [23]
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All investigator physicians and nurses involved in this study were asked to provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (\<) 1 hr, at least 1 hr but \<2 hrs, at least 2 hrs but \<3 hrs, at least 3 hrs but \<4 hrs, \>/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV.
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Timepoint [23]
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After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)
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Secondary outcome [24]
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Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion
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Assessment method [24]
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All investigator physicians and nurses involved in this study were asked to complete question i.e. "Which formulation of rituximab (SC or IV) do you think is more convenient?" based on their experience with the rituximab SC and IV formulations across all participants and presented as rituximab SC is much more convenient; rituximab SC is a little more convenient; both formulations are equally convenient; rituximab IV is a little more convenient; and rituximab IV is much more convenient.
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Timepoint [24]
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After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)
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Eligibility
Key inclusion criteria
* Cluster of differentiation 20 (CD20)-positive, follicular Non-Hodgkin's lymphoma grade 1, 2, 3a. A tumor biopsy must have been performed within 6 months before study entry with material available for central review
* No prior treatment
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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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
* Grade 3b follicular lymphoma
* Transformation to high-grade lymphoma secondary to follicular lymphoma
* Types of Non-Hodgkin's lymphoma other than follicular lymphoma
* Presence or history of central nervous system (CNS) disease
* Corticoid therapy during the last 4 weeks, except prednisone treatment less than (<) 20 milligrams per day (mg per day)
* Known active bacterial, viral, fungal, or mycobacterial, or any major episode of infections requiring hospitalization or treatment with IV antibiotics within 4 weeks of start of study medication, or oral antibiotics within 2 weeks prior to start of study medication
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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 3
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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
15/02/2011
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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
31/10/2017
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Sample size
Target
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Accrual to date
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Final
410
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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Gosford Hospital; Cancer Care Services - Gosford
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Recruitment hospital [2]
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Wollongong Hospital; Cancer Services - Wollongong
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Recruitment hospital [3]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [4]
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Gold Coast Hospital; Haematology Department - Southport
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Recruitment hospital [5]
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Queen Elizabeth Hospital; Haematology - Woodville South
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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4215 - Southport
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Recruitment postcode(s) [5]
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5011 - Woodville South
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Recruitment outside Australia
Country [1]
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0
Belgium
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State/province [1]
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0
Edegem
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Country [2]
0
0
Belgium
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State/province [2]
0
0
Liège
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Country [3]
0
0
Belgium
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State/province [3]
0
0
Wilrijk
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Country [4]
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Wolverhampton
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Funding & Sponsors
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Hoffmann-La Roche
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Summary
Brief summary
This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m\^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.
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Trial website
https://clinicaltrials.gov/study/NCT01200758
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Trial related presentations / publications
Davies A, Merli F, Mihaljevic B, Mercadal S, Siritanaratkul N, Solal-Celigny P, Boehnke A, Berge C, Genevray M, Zharkov A, Dixon M, Brewster M, Barrett M, MacDonald D. Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial. Lancet Haematol. 2017 Jun;4(6):e272-e282. doi: 10.1016/S2352-3026(17)30078-9. Epub 2017 May 2. Davies A, Merli F, Mihaljevic B, Siritanaratkul N, Solal-Celigny P, Barrett M, Berge C, Bittner B, Boehnke A, McIntyre C, Macdonald D. Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol. 2014 Mar;15(3):343-52. doi: 10.1016/S1470-2045(14)70005-1. Epub 2014 Feb 10. Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013. Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013 Sep 17;109(6):1556-61. doi: 10.1038/bjc.2013.371. Epub 2013 Sep 3.
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Public notes
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Contacts
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https://clinicaltrials.gov/study/NCT01200758
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