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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021377-36 |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | Active Comparator | 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. |
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| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab SC | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab | Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks) | |
| 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) | 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. | Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gosford Hospital; Cancer Care Services | Gosford | New South Wales | 2250 | Australia | ||
| Wollongong Hospital; Cancer Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28476440 | Derived | 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. | |
| 24521993 |
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Screening/baseline tests were performed within 28 days before randomization. Randomization was centralized in a 1:1 fashion using the Pocock and Simon dynamic randomization algorithm. The study was conducted in 2 stages: Stage I & II. All participants irrespective of the treatment period completion commenced follow-up period in both Stage I and II.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | Eight cycles of rituximab intravenous (IV) infusion (375 milligrams per square meter [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 partial response (PR) during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage I |
|
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| Rituximab IV | Drug | 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. |
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| Cyclophosphamide | Drug | Eight cycles of cyclophosphamide (750 mg/m^2 IV) administered every 3 weeks. |
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| Doxorubicin | Drug | Eight cycles of doxorubicin (50 mg/m^2 IV) administered every 3 weeks. |
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| Vincristine | Drug | Eight cycles of doxorubicin (1.4 mg/m^2 IV) administered every 3 weeks. |
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| Prednisone/Prednisolone | Drug | 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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| Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
| 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 | 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. | Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
| Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | 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. | Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
| Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | 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. | Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
| 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 | 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. | Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
| 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 | 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. | 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) |
| 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 | 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. | 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) |
| Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death | 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]) | 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) |
| Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL | 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]) | 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) |
| 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 | 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]) | 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) |
| Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL | 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]) | 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) |
| Percentage of Participants Who Died | Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years]) |
| Overall Survival (OS) | 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. | Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years]) |
| Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab | 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]) | 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) |
| Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab | 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]) | 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) |
| Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle | 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]) | 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) |
| Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle | 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]) | 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) |
| Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration | 12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years]) |
| Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase | Depletion is defined as a cluster of differentiation (CD) 19 value <80 cells per cubic millimeter (cells/mm^3). | 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 |
| Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase | Depletion is defined as a CD19 value <80 cells/mm^3. | 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]) |
| Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab | 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]) | Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description) |
| Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab | 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]) | Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description) |
| 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 | 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. | 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) |
| Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion | 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. | 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) |
| Wollongong |
| New South Wales |
| 2500 |
| Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Gold Coast Hospital; Haematology Department | Southport | Queensland | 4215 | Australia |
| Queen Elizabeth Hospital; Haematology | Woodville South | South Australia | 5011 | Australia |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept | Banja Luka | 88000 | Bosnia and Herzegovina |
| University Clinical Center Sarajevo, Clinic for Hematology | Sarajevo | 71000 | Bosnia and Herzegovina |
| University Clinical Centre Tuzla, Clinic for Oncology, Hematology and Radiotherapy | Tuzla | 75000 | Bosnia and Herzegovina |
| Nucleo de Hematologia e Transplante de Medula Ossea de Minas Gerais | Belo Horizonte | Minas Gerais | 30140-001 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia | São Paulo | São Paulo | 01221-020 | Brazil |
| Hospital das Clinicas - FMUSP | São Paulo | São Paulo | 05403-000 | Brazil |
| UMHAT Dr Georgi Stranski; Hematology | Pleven | 5800 | Bulgaria |
| Umhat S. George; Hematology | Plovdiv | 4002 | Bulgaria |
| Specialised Hospital For Treatment Of Hematological Diseases; Hematology | Sofia | 1756 | Bulgaria |
| Mhat Sveta Marina; Dept. of Haematology | Varna | 9010 | Bulgaria |
| Queen Elizabeth II Health Sciences Centre; Oncology | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Cite de La Sante de Laval; Hemato-Oncologie | Laval | Quebec | H7M 3L9 | Canada |
| Centre de sante et de services sociaux Rimouski Neigette | Rimouski | Quebec | G5L 5T1 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Centre hospitalier regional de Trois-Rivieres | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie | Québec | G1J 1Z4 | Canada |
| Fundacion Cardioinfantil | Bogotá | Colombia |
| Centro Medico Imbanaco | Cali | Colombia |
| Hospital Pablo Tobon Uribe | Medellin-Antioquia | Colombia |
| Oncólogos de Occidente | Pereira | 600004 | Colombia |
| UHC Rijeka | Rijeka | 51000 | Croatia |
| University Hospital Center Zagreb; Haematology Department | Zagreb | 10000 | Croatia |
| Aarhus Universitetshospital, Hæmatologisk Afdeling R | Aarhus | 8000 | Denmark |
| Herlev Uni Hospital; Hæmatologisk Afdeling L 121 | Herlev | 2730 | Denmark |
| Rigshospitalet; Hæmatologisk Klinik | København Ø | 2100 | Denmark |
| Odense Universitetshospital; Hæmatologisk Afdeling | Odense C | 5000 | Denmark |
| Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium | Roskilde | 4000 | Denmark |
| Vejle Hospital; Dept of Medicine, Division of Hematology | Vejle | 7100 | Denmark |
| Helsinki University Central Hospital; Dept of Oncology | Helsinki | 00029 | Finland |
| Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie | Bordeaux | 33077 | France |
| Hopital Henri Mondor; Hematologie Clinique | Créteil | 94010 | France |
| Chu Site Du Bocage;Hematologie Clinique | Dijon | 21079 | France |
| Clinique Victor Hugo; Chimiotherapie | Le Mans | 72015 | France |
| Institut J Paolii Calmettes; Onco Hematologie 1 | Marseille | 13273 | France |
| Hopital Saint Eloi; Hematologie Oncologie Medicale | Montpellier | 34295 | France |
| Hopital Hotel Dieu Et Hme;Hopital De Jour | Nantes | 44093 | France |
| Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset) | Paris | 75475 | France |
| Hopital De Haut Leveque; Hematologie Clinique | Pessac | 33604 | France |
| Ch Lyon Sud; Hemato Secteur Jules Courmont | Pierre-Bénite | 69495 | France |
| Hopital De La Miletrie; Hematologie Et Oncologie Medicale | Poitiers | 86021 | France |
| Hopital Bretonneau; Hematologie Therapie Cellulaire | Tours | 37044 | France |
| M.Zodelava's Hematology Center | Tbilisi | 0112 | Georgia |
| Mediclub | Tbilisi | 0160 | Georgia |
| Institute of Hematology and Transfusiology | Tbilisi | 0177 | Georgia |
| Chemotherapy and Immunotherapy Clinic Medulla | Tbilisi | 0186 | Georgia |
| Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin | 10707 | Germany |
| Gemeinschaftspraxis PD Dr. med. Marcel Reiser und Dr. med. Ildiko Kátay | Cologne | 50674 | Germany |
| Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie | Darmstadt | 64283 | Germany |
| Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin | Dresden | 01307 | Germany |
| PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann | Frechen | 50226 | Germany |
| Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I | Giessen | 35392 | Germany |
| Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik | Greifswald | 17475 | Germany |
| Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw. | Halle | 06110 | Germany |
| Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie | Hanover | 30625 | Germany |
| St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2 | Karlsruhe | 76137 | Germany |
| UKSH Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie | Kiel | 24105 | Germany |
| Onkologische Gemeinschaftspraxis | Magdeburg | 39104 | Germany |
| Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach | Marburg | 35037 | Germany |
| Medizinisches Versorgungszentrum MOP | München | 80335 | Germany |
| Praxis Dr.med. Jens Uhlig | Naunhof | 04683 | Germany |
| Praxis Dr. Clemens Müller-Naendrup (Onkologische Schwerpunktpraxis im MVZ 2 GmbH) | Olpe | 57462 | Germany |
| Prosper-Hospital, Medizinische Klinik I | Recklinghausen | 45659 | Germany |
| Praxis Dr. Fenchel | Saalfeld | 07318 | Germany |
| Caritas Kilinik St. Theresia; Abt. Innere Medizin | Saarbrücken | 66113 | Germany |
| Praxis für Hämatologie & Onkologie | Saarbrücken | 66113 | Germany |
| Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine | Athens | 115 27 | Greece |
| Attiko Hospital; Haematology Clinic | Athens | 124 62 | Greece |
| IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo | San Giovanni Rotondo | Apulia | 71013 | Italy |
| Azienda Ospedaliera Ospedale S.Carlo; Ematologia | Potenza | Basilicate | 85100 | Italy |
| A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica | Naples | Campania | 80131 | Italy |
| AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Ospedale S. Eugenio; Divisione Di Ematologia | Rome | Lazio | 00144 | Italy |
| Uni Degli Studi Di Genova; 1A Divisione Di Ematologia | Genoa | Liguria | 16132 | Italy |
| A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia | Brescia | Lombardy | 25123 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia | Milan | Lombardy | 20141 | Italy |
| Ospedale Ca Foncello; Ematologia | Treviso | Veneto | 31100 | Italy |
| Ospedale Di Vicenza; Nefrologia, Ematologia | Vicenza | Veneto | 36100 | Italy |
| University Malaya Medical Center; Hematology Unit of Department of Internal Medicine | Kuala Lumpur | FED. Territory of Kuala Lumpur | 59100 | Malaysia |
| Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care | Sarawak | Sarawak | 93586 | Malaysia |
| Ampang Hospital; Department of Haematology | Ampang | 68000 | Malaysia |
| Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre | Chihuahua City | 31000 | Mexico |
| Hospital General De Culiacan; Servicio De Hematologia | Culiacán | 80230 | Mexico |
| Hospital Universitario Dr. Jose E. Gonzalez; Haematology | Monterrey | 64460 | Mexico |
| Centro de Estudios Clinicos de Queretaro (CECLIQ) | Querétaro | 76000 | Mexico |
| Canterbury Health Laboratories; Haematology | Christchurch | 8011 | New Zealand |
| Palmerston North Hospital; Regional Cancer Treatment Service | Palmerston North | 4442 | New Zealand |
| University Clinic for Hematology; HSCT Department | Skopje | 1000 | North Macedonia |
| University Clinic of Hematology Skopje, Hospital Care Department | Skopje | 1000 | North Macedonia |
| Instituto;Oncologico Miraflores | Lima | 18 | Peru |
| Oncosalud Sac; Oncología | Lima | 41 | Peru |
| Hospital Maria Auxiliadora | Lima | Lima 29 | Peru |
| Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie | Brasov | 500326 | Romania |
| Fundeni Clinical Inst. ; Hematology Dept | Bucharest | 022328 | Romania |
| Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie | Iași | 700111 | Romania |
| Institutul Regional de Oncologie Iasi; Clinica de Hematologie | Iași | 700483 | Romania |
| Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie | Târgu Mureş | 540136 | Romania |
| Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie | Timișoara | 300079 | Romania |
| Clinical Oncology Dispensary of Ministry of Health of Tatarstan | Kazan' | 420029 | Russia |
| N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis | Moscow | 115478 | Russia |
| Haematology Research Center; Haematology | Moscow | 125167 | Russia |
| Penza Regional Oncology Dispensary | Penza | 440071 | Russia |
| Research Inst. of Hematology & Blood Transfusion ; Hematology | Saint Petersburg | 191024 | Russia |
| St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta | Saint Petersburg | 197022 | Russia |
| Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology | St.Petersburg, Pesochny | 197758 | Russia |
| Institute of Hematology | Belgrade | 11000 | Serbia |
| Clinical Center Vojvodine; Clinic for Hematology | Novi Sad | 21000 | Serbia |
| National University Hospital; National University Cancer Institute, Singapore (NCIS) | Singapore | 119228 | Singapore |
| Singapore General Hospital; Department of Haematology | Singapore | 169608 | Singapore |
| National Cancer Centre; Medical Oncology | Singapore | 169610 | Singapore |
| St. Elisabeths Cancer Center | Bratislava | 812 50 | Slovakia |
| National Cancer Inst. ; Dept. of Chemotherapy | Bratislava | 833 10 | Slovakia |
| National Hospital; Oncotherapy Dept | Bloemfontein | 9301 | South Africa |
| Durban Oncology Center | Durban | 4091 | South Africa |
| University of Witwatersrand/Johannesburg Hospital; Dept. of ocnology | Johannesburg | 2193 | South Africa |
| Cancercare | Kraaifontein | 7570 | South Africa |
| King Edward VIII; Department of Haematology | KwaKhangela | 4013 | South Africa |
| Hospital Universitario Puerta del Mar; Servicio de Hematologia | Cadiz | Cadiz | 11009 | Spain |
| Hospital del Mar; Servicio de Hematologia | Barcelona | 08003 | Spain |
| Hospital Universitari Vall d'Hebron; Servicio de Hematologia | Barcelona | 08035 | Spain |
| Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | 08036 | Spain |
| Hospital Duran i Reynals; Servicio de Hematologia | Barcelona | 08907 | Spain |
| Hospital Universitario de la Princesa; Servicio de Hematologia | Madrid | 28006 | Spain |
| Hospital Ramon y Cajal; Servicio de Hematologia | Madrid | 28034 | Spain |
| Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia | Murcia | 30120 | Spain |
| Hospital Clinico Universitario de Salamanca;Servicio de Hematologia | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Hematologia | Seville | 41013 | Spain |
| Hospital Universitario la Fe; Servicio de Oncologia | Valencia | 46026 | Spain |
| National Cancer Inst. | Bangkok | 10400 | Thailand |
| Siriraj Hospital; Division of Hematology, Department of Medicine | Bangkok | 10700 | Thailand |
| Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine | Khon Kaen | 40002 | Thailand |
| Adana Baskent University Hospital; Medical Oncology | Adana | 01120 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty; Hematology Department | Istanbul | 34098 | Turkey (Türkiye) |
| Bilim University School of Medicine; Hematology | Istanbul | 34394 | Turkey (Türkiye) |
| Dokuz Eylul Uni ; Hematology | Izmir | 35100 | Turkey (Türkiye) |
| Ege Uni Medical School; Hematology | Izmir | 35100 | Turkey (Türkiye) |
| Ninewells Hospital & Medical School; Ward 34 | Dundee | DD1 9SY | United Kingdom |
| Maidstone & Tonbridge Wells Hospital; Kent Oncology Center | Maidstone | ME16 9QQ | United Kingdom |
| Derriford Hospital; Department of Haematology | Plymouth | PL6 8DH | United Kingdom |
| Queen's Hospital; Oncology | Romford | RM7 0AG | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Pinderfields General Hospital; Dept of Haematology | Wakefield | WF1 4DG | United Kingdom |
| New Cross Hospital; Dept. Of Haematology | Wolverhampton | WV10 0QP | United Kingdom |
| Derived |
| 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. |
| 24265828 | Derived | 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. |
| 24002601 | Derived | 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. |
| FG001 | Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (SC) (1400 milligrams [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 during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. |
| FG002 | Stage 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 CHOP or 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. |
| FG003 | Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | First cycle of rituximab IV (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. |
| COMPLETED |
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| NOT COMPLETED |
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| Stage 2 |
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Intent-to-Treat (ITT) Population included all participants who were randomized into study irrespective whether they received study drug or not.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 CHOP or 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. |
| BG001 | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab | Stage I pharmacokinetic (PK) evaluable population comprised all participants with data for Ctrough available at Cycle 7 and/or observed area under the serum concentration-time curve (AUC) available at Cycle 7. Participants were analyzed as per treatment received. Number of participants analyzed = participants analyzed for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (mcg/mL) | 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 | 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) | 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. | Stage II ITT Population included all participants who were randomized in Stage II irrespective whether they received study drug or not. | Posted | Number | 95% Confidence Interval | percentage of participants | Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
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| Secondary | Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | 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. | Stage I ITT Population included all participants who were randomized in Stage I irrespective whether they received study drug or not. | Posted | Number | 95% Confidence Interval | percentage of participants | Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
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| Secondary | 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 | 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. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
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| Secondary | Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | 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. | Stage I ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
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| Secondary | Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL | 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. | Stage II ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
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| Secondary | 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 | 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. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks) |
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| Secondary | 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 | 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. | ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 | 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 | 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. | ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 | Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death | 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]) | ITT Population. | Posted | Number | percentage of participants | 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 | Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL | 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]) | ITT Population. | Posted | Median | 95% Confidence Interval | days | 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 | 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 | 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]) | ITT population. | Posted | Number | percentage of participants | 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 | Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL | 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]) | ITT population. | Posted | Median | 95% Confidence Interval | days | 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 | Percentage of Participants Who Died | ITT population. | Posted | Number | percentage of participants | Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years]) |
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| Secondary | Overall Survival (OS) | 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. | ITT population. | Posted | Median | 95% Confidence Interval | days | Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years]) |
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| Secondary | Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab | 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]) | Stage I PK evaluable population. Here, number of participants analyzed = participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*day/mL | 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 | Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab | 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]) | Stage 1 PK Evaluable Population. Here, number of participants analyzed = participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | 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 | Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle | 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]) | ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | 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 | Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle | 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]) | ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | 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) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration | Safety Analysis Population included all participants who received at least one dose of rituximab, either IV or SC. Participants were analyzed as treated. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint. | Posted | Median | Full Range | mcg/mL | 12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years]) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase | Depletion is defined as a cluster of differentiation (CD) 19 value <80 cells per cubic millimeter (cells/mm^3). | ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint. | Posted | Number | percentage of participants | 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase | Depletion is defined as a CD19 value <80 cells/mm^3. | ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint. | Posted | Number | percentage of participants | 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]) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab | 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]) | Safety Analysis Population: included 6 participants who were randomized under Rituximab SC arm but withdrew after Cy1 and then analyzed under Rituximab IV arm. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint. | Posted | Number | percentage of participants | Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab | 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]) | Safety Analysis Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint. | Posted | Number | percentage of participants | Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint. | Posted | Number | percentage of responses | 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 | Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion | 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. | ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint. | Posted | Number | percentage of responses | 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) |
|
Baseline up to data cutoff date of 31 Oct 2017 (up to 6 years)
Safety Analysis Population included all participants who received at least one dose of rituximab, either IV or SC. Safety Analysis Population included 6 participants who were randomized under Rituximab SC arm but withdrew after Cy1 and then analyzed under Rituximab IV arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 CHOP or 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. | 76 | 210 | 187 | 210 | ||
| EG001 | 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. | 74 | 197 | 186 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Bacterial prostatitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Creutzfeldt-Jakob disease | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Oral lichen planus | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Coma hepatic | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Eastern Cooperative Oncology Group performance status worsened | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pelvic cyst | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Chronic hepatitis B | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hepatitis viral | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Intestinal sepsis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Respiratory tract infection fungal | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cervix Carcinoma Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Subclavian artery occlusion | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bladder calculus removal | Surgical and medical procedures | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA (18.1) | Non-systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cellulitis gangrenous | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | global-roche-genentech-trials@gene.com |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011246 | Pregnadienetriols |
Not provided
Not provided
| Lack of Efficacy |
|
| Physician Decision |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Death |
|
| Male |
|
| OG001 | Stage 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. |
|
|
|
| Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) |
First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (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 during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. |
|
|
|
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. |
|
|
|
First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab subcutaneously (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 during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
|
|
|
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.
|
|
|
First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
|
|
|
| OG001 | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. |
|
|
|
| OG001 | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. |
|
|
|
|
|
| OG001 | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. |
|
|
|
First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
|
|
First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
|
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| Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
|
|
|
|
|
|
|
|