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This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC) administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL) (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell lymphoma (DLBCL) (treatment plus 24 months of follow-up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental | Participants with FL and DLBCL will receive rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab SC 1400 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Administration-Associated Reactions (AARs) | AARs defined as all related adverse events (AEs) occurring within 24 hours of rituximab SC administration, including infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. | Within 24 hours of each rituximab SC administration (maximum treatment duration up to 32 months for FL participants and up to 8 months for DLBCL participants) |
| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria | EFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to first occurrence of progression or relapse, according to the IWG response criteria or other country standards, or initiation of a non-protocolspecified anti-lymphoma therapy or death, whichever occurs first. |
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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 |
|---|---|---|---|---|---|---|
| Hôpital Dorban CHU Annaba, Service d'Hématologie | Annaba | 23000 | Algeria | |||
| EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward |
139 participants (105 with DLBCL and 34 with FL) in the intent-to-treat (ITT) population; 122 participants (95 with DLBCL and 27 with FL) in the safety population. From 139 participants, 122 were dosed at least 1 dose were included in Safety Analysis Set.
Total of 139 participants mentioned below in the table were recruited and enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | DLBCL Arm | Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2016 | Jun 14, 2022 |
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| Cyclophosphamide | Drug | Cyclophosphamide will be administered as per standard local practice. |
|
|
| Doxorubicin | Drug | Doxorubicin will be administered as per standard local practice. |
|
| Vincristine | Drug | Vincristine will be administered as per standard local practice. |
|
| Prednisone | Drug | Prednisone will be administered as per standard local practice. |
|
| Fludarabine | Drug | Fludarabine will be administered as per standard local practice. |
|
| From first dose of rituximab intravenous (IV) and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months]) |
| Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria | PFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to the first occurrence of progression or relapse, according to the IWG response criteria (Cheson et al. 1999) or other country standards, or death from any cause. | From first dose of rituximab IV and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months]) |
| Overall Survival (OS) | OS is defined as the time from first dose of rirtuximab (analysed using both first dose of IV and first dose of SC) until death from any cause. | From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [Up to 51.1 Months]) |
| Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria | DFS will be assessed at the end of induction treatment in patients achieving CR/CRu and is defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. | From the date of the initial complete response (CR)/complete response unconfirmed (CRu) until date of relapse or death from any cause (up to end of induction treatment [Up to 32.7 Months]) |
| Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria | CR/CRu: Response assessments 4 - 6 weeks after the last dose of induction treatment will be based on the Investigator's assessment, completed according to the original International Working Group (IWG) response criteria for response assessment of lymphoma (Cheson et al. 1999). | From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [Up to 32 Months]) |
| Healthcare Professional Questionnaire Score | Planned Healthcare Professional Questionnaiere was not collected during the study therefore no data to report | End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants) |
| Patient-Reported Rituximab Administration Questionnaire (RASQ) Score | The RASQ measures the overall participant satisfaction and is a 20-item questionnaire measuring the impact of the treatment administration on 5 domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. Each question's answer is chosen from 1 (minimum)-5(maximum score indicating less severity) score range. For each domain was scored using the following formula: Domain score = [(Sum of completed item (question) responses / Number of completed items) - 1] x 100 / (Maximum possible item response value - Minimum possible item response value) The final RASQ domains is calculated using the formula: RASQ domain score = (Mean of completed item responses - 1) x 25, scores ranging from 1-100 with higher scores indicative of more positive feelings toward therapy. Lower number representing lower satisfaction and higher is the higher satisfaction by the participants. | Up to 53.8 Months |
| Blida |
| 09000 |
| Algeria |
| EHU Oran, Service d'Hématologie et de Thérapie Cellulaire | Oran | 31000 | Algeria |
| Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie | Tizi Ouzou | 15000 | Algeria |
| CHU 20 Aout Service D'Onco-Hematologie Pediatrique | Casablanca | 20100 | Morocco |
| Clinique AlMadina; Service hematologie | Casablanca | 20340 | Morocco |
| Centre Hospitalier Uni Ire de Marrakech; Oncologie-Hématologie | Marrakesh | 40000 | Morocco |
| Hôpital d'enfants de Rabat - Service d'hémato-oncologie pédiatrique | Rabat | 10090 | Morocco |
| CHU Fattouma Bourguiba, Monastir; Service d'hématologie | Monastir | 5000 | Tunisia |
| CHU Hédi Chacker; Service d'hématologie | Sfax | 3025 | Tunisia |
| CHU Farhat Hached; Service d'hématologie | Sousse | 4000 | Tunisia |
| Aziza Othmana Hospital; Clinical Haematology | Tunis | 1008 | Tunisia |
| Hopital Militaire d'instruction de Tunis; Service d'hématologie | Tunis | 1008 | Tunisia |
| FG001 | FL Arm | Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DLBCL Arm | Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction. |
| BG001 | FL Arm | Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Administration-Associated Reactions (AARs) | AARs defined as all related adverse events (AEs) occurring within 24 hours of rituximab SC administration, including infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. | Safety Population | Posted | Number | Percentage of Participants % | Within 24 hours of each rituximab SC administration (maximum treatment duration up to 32 months for FL participants and up to 8 months for DLBCL participants) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival (EFS) as Assessed by Investigator According to International Working Group (IWG) Response Criteria | EFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to first occurrence of progression or relapse, according to the IWG response criteria or other country standards, or initiation of a non-protocolspecified anti-lymphoma therapy or death, whichever occurs first. | ITT | Posted | Median | 95% Confidence Interval | Months | From first dose of rituximab intravenous (IV) and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months]) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) as Assessed by Investigator According to IWG Response Criteria | PFS is defined as the time from first dose of rituximab (analysed using both first dose of IV and first dose of SC) to the first occurrence of progression or relapse, according to the IWG response criteria (Cheson et al. 1999) or other country standards, or death from any cause. | ITT | Posted | Median | 95% Confidence Interval | Months | From first dose of rituximab IV and SC until first occurrence of progression or relapse (up to end of induction treatment [Up to 53.8 Months]) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from first dose of rirtuximab (analysed using both first dose of IV and first dose of SC) until death from any cause. | ITT | Posted | Median | 95% Confidence Interval | Months | From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [Up to 51.1 Months]) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease-Free Survival (DFS) as Assessed by Investigator According to IWG Response Criteria | DFS will be assessed at the end of induction treatment in patients achieving CR/CRu and is defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. | ITT | Posted | Median | 95% Confidence Interval | Months | From the date of the initial complete response (CR)/complete response unconfirmed (CRu) until date of relapse or death from any cause (up to end of induction treatment [Up to 32.7 Months]) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CR/CRu as Assessed by Investigator According to IWG Response Criteria | CR/CRu: Response assessments 4 - 6 weeks after the last dose of induction treatment will be based on the Investigator's assessment, completed according to the original International Working Group (IWG) response criteria for response assessment of lymphoma (Cheson et al. 1999). | ITT | Posted | Number | 95% Confidence Interval | Percentage | From first dose of rituximab until first occurrence of progression or relapse (up to end of induction treatment [Up to 32 Months]) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Healthcare Professional Questionnaire Score | Planned Healthcare Professional Questionnaiere was not collected during the study therefore no data to report | Posted | End of treatment (Month 24 for FL participants and Month 8 for DLBCL participants) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Patient-Reported Rituximab Administration Questionnaire (RASQ) Score | The RASQ measures the overall participant satisfaction and is a 20-item questionnaire measuring the impact of the treatment administration on 5 domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. Each question's answer is chosen from 1 (minimum)-5(maximum score indicating less severity) score range. For each domain was scored using the following formula: Domain score = [(Sum of completed item (question) responses / Number of completed items) - 1] x 100 / (Maximum possible item response value - Minimum possible item response value) The final RASQ domains is calculated using the formula: RASQ domain score = (Mean of completed item responses - 1) x 25, scores ranging from 1-100 with higher scores indicative of more positive feelings toward therapy. Lower number representing lower satisfaction and higher is the higher satisfaction by the participants. | Safety Population | Posted | Mean | Standard Deviation | Scores on a Scale | Up to 53.8 Months |
|
From first dose of rituximab IV and SC until death from any cause (up to end of induction treatment [up to 53.8 Months])
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DLBCL Arm | Participants with DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction. | 22 | 95 | 11 | 95 | 58 | 95 |
| EG001 | FL Arm | Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction. | 5 | 27 | 8 | 27 | 12 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Blood and | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Bone Marrow Failure | Blood and lymphatic system disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDra 24.1 | Non-systematic Assessment |
| |
| Candida Infection | Infections and infestations | MedDra 24.1 | Non-systematic Assessment |
| |
| Hepatitis B Reactivation | Infections and infestations | MedDra 24.1 | Non-systematic Assessment |
| |
| Klebsiella Bacteraemia | Infections and infestations | MedDra 24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 24.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDra 24.1 | Non-systematic Assessment |
| |
| Fibula Fracture | Injury, poisoning and procedural complications | MedDra 24.1 | Non-systematic Assessment |
| |
| Liver Function Test Abnormal | Investigations | MedDra 24.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.1 | Non-systematic Assessment |
| |
| Haemorrhagic Stroke | Nervous system disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDra 24.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDra 24.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDra 24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 24.1 | 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 | Hoffman-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 4, 2022 | Jun 14, 2022 | SAP_001.pdf |
| 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 |
| C024352 | fludarabine |
| 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 |
Not provided
Not provided
| Male |
|
| Hispanic or Latino |
|
| Other |
|
| Not applicable as per local regulations |
|
|
| Blood And Lymphatic System Disorders, Thrombocytopenia |
|
| General Disorders And Administration Site Conditions, Injection Site Erythema |
|
| General Disorders And Administration Site Conditions, Injection Site, Injection Site Pain |
|
| Nervous System Disorders, Burning Sensation |
|
| Nervous System Disorders, Paraesthesia |
|
| Skin And Subcutaneous Tissue Disorders, Erythema |
|
| Skin And Subcutaneous Tissue Disorders, Dermatitis Allergic |
|
| OG002 | Overall | All participants received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction. |
|
|
| OG002 | Overall Population | Participants received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction |
|
|
| OG002 | Overall Population | All participants received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction. |
|
|
| OG002 | Overall Population | All participants received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction |
|
|
| OG002 | Overall Population | All participants received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction. |
|
|
| OG001 |
| FL Arm |
Participants with FL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction |
| OG002 | Overall Population | Participants with FL and DLBCL received rituximab SC 1400 milligrams (mg) once a month for a minimum of 4 cycles as induction therapy. Participants with FL will continue to receive rituximab once in 2 months for a minimum of 6 cycles as maintenance therapy according to local standards of care. Participants will also receive standard chemotherapy regimen (CHOP [cyclophosphamide+doxorubicin+vincristine+prednisone], CVP [cyclophosphamide+vincristine+prednisone] or FC [fludarabine+cyclophosphamide]) during induction. |
|
|