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This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Drug | 1 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date | Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures. | Month 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase | CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia | Pescara | Abruzzo | 65100 | Italy | ||
| Ospedale Civile; Divisione Di Oncologia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab + Fludarabine + Cyclophosphamide | Cycle 1 (28-day cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with complete response (CR), unconfirmed complete response (CRu), or partial response (PR), received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Phase (Months 1 to 7 of Study) |
|
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| Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase) |
| Percentage of Participants Achieving a Response by Response Type and Study Phase | CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders. | Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40 |
| Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death | FFS data were analyzed using Kaplan-Meier survival analysis. FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or dropped out due to adverse events (AE) were censored at their last assessment date. The reported data refer to values up to 40 months. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
| FFS - Percentage of Participants With an Event | FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or who dropped out due to AEs were censored at their last assessment date. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
| FFS - Time to Event | FFS was measured from the date of treatment start to the date of documented disease progression, relapse or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent or dropped out due to AEs were censored at their last assessment date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
| Overall Survival (OS) - Percentage of Participants Estimated to be Alive | OS data were analyzed using Kaplan-Meier survival analysis. OS was defined as the time from first dosage of study drug to the date of death from any cause. Reported data refer to values up to 40 months. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
| OS - Percentage of Participants With an Event | OS was defined as the time from first dosage of study drug to the date of death from any cause. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. |
| OS - Time to Event | Overall survival was defined as the time from first dosage of study drug to the date of death from any cause. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. |
| Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free | DFS data were analyzed using Kaplan-Meier survival analysis. DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of CR to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored as of the death date. The reported data refer to values up to 40 months. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
| DFS - Percentage of Participants With an Event | DFS was defined for all patients who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. |
| DFS - Time to Event | DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. |
| Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free | PFS data were analyzed using Kaplan-Meier survival analysis. PFS was defined as the time from treatment start to the date of documented disease progression. Reported data refer to values up to 40 months. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
| PFS - Percentage of Participants With an Event | Progression-free survival was defined as the time from the date of treatment start to the date of documented disease progression. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
| PFS - Time to Event | Progression-free survival was defined as the time from treatment start to the date of documented disease progression. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
| Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response | DR data were analyzed using Kaplan-Meier survival analysis. DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
| DR - Percentage of Participants With an Event | DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
| DR - Time to Event | DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date. | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
| Pescara |
| Abruzzo |
| 65124 |
| Italy |
| Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia | Rionero in Vulture | Basilicate | 85028 | Italy |
| Ospedale Riuniti; Divisione Di Ematologia | Reggio Calabria | Calabria | 89100 | Italy |
| A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica | Modena | Emilia-Romagna | 41100 | Italy |
| Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA | Rome | Lazio | 00161 | Italy |
| A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia | Brescia | Lombardy | 25123 | Italy |
| Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora | Milan | Lombardy | 20122 | Italy |
| Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia | Milan | Lombardy | 20162 | Italy |
| Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia | Alessandria | Piedmont | 15121 | Italy |
| Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia | Cuneo | Piedmont | 12100 | Italy |
| A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1 | Turin | Piedmont | 10126 | Italy |
| Az. Osp. Papardo; Struttura Complessa Di Ematologia | Messina | Sicily | 98165 | Italy |
| Az. Osp. Di Careggi; Divisione Di Ematologia | Florence | Tuscany | 50135 | Italy |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Maintenance Phase (Months 8-16 of Study) |
|
|
| Follow-up (Months 17-40 of Study) |
|
|
Intent-to-Treat (ITT) population: all enrolled participants who completed at least 2 cycles of treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab + Fludarabine + Cyclophosphamide | Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date | Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Month 28 |
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| Secondary | Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase | CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase) |
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| Secondary | Percentage of Participants Achieving a Response by Response Type and Study Phase | CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders. | ITT population | Posted | Number | percentage of participants | Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40 |
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| Secondary | Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death | FFS data were analyzed using Kaplan-Meier survival analysis. FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or dropped out due to adverse events (AE) were censored at their last assessment date. The reported data refer to values up to 40 months. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
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| Secondary | FFS - Percentage of Participants With an Event | FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or who dropped out due to AEs were censored at their last assessment date. | ITT population | Posted | Number | percentage of participants | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
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| Secondary | FFS - Time to Event | FFS was measured from the date of treatment start to the date of documented disease progression, relapse or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent or dropped out due to AEs were censored at their last assessment date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | ITT population | Posted | Mean | Standard Error | months | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
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| Secondary | Overall Survival (OS) - Percentage of Participants Estimated to be Alive | OS data were analyzed using Kaplan-Meier survival analysis. OS was defined as the time from first dosage of study drug to the date of death from any cause. Reported data refer to values up to 40 months. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
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| Secondary | OS - Percentage of Participants With an Event | OS was defined as the time from first dosage of study drug to the date of death from any cause. | ITT population | Posted | Number | percentage of participants | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. |
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| Secondary | OS - Time to Event | Overall survival was defined as the time from first dosage of study drug to the date of death from any cause. | ITT population | Posted | Mean | Standard Error | months | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. |
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| Secondary | Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free | DFS data were analyzed using Kaplan-Meier survival analysis. DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of CR to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored as of the death date. The reported data refer to values up to 40 months. | ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
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| Secondary | DFS - Percentage of Participants With an Event | DFS was defined for all patients who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date. | ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis. | Posted | Number | percentage of participants | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. |
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| Secondary | DFS - Time to Event | DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis. | Posted | Mean | Standard Error | months | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. |
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| Secondary | Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free | PFS data were analyzed using Kaplan-Meier survival analysis. PFS was defined as the time from treatment start to the date of documented disease progression. Reported data refer to values up to 40 months. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
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| Secondary | PFS - Percentage of Participants With an Event | Progression-free survival was defined as the time from the date of treatment start to the date of documented disease progression. | ITT population | Posted | Number | percentage of participants | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
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| Secondary | PFS - Time to Event | Progression-free survival was defined as the time from treatment start to the date of documented disease progression. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | ITT population | Posted | Mean | Standard Error | months | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
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| Secondary | Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response | DR data were analyzed using Kaplan-Meier survival analysis. DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date. | ITT population; only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
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| Secondary | DR - Percentage of Participants With an Event | DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date. | ITT population; only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis. | Posted | Number | percentage of participants | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
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| Secondary | DR - Time to Event | DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date. | ITT population: only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis. | Posted | Mean | Standard Error | months | Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 |
|
Treatment-emergent adverse events (AEs) were reported throughout the study (up to 40 months).
Not provided
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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 | Rituximab + Fludarabine + Cyclophosphamide | Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest. Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest. Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest. Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times. | 16 | 47 | 47 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal dysplasia | Congenital, familial and genetic disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Visual disturbance | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Amyloidosis | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Erythema induratum | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Beta 2 microglobulin increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Red blood cell sedimentation rate increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gynaecomasatia | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Ureterectomy | Surgical and medical procedures | MedDRA (10.1) | Non-systematic Assessment |
| |
| Aortic thrombosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA (10.1) | 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 the 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-LaRoche | 800-821-8590 | genentech@druginfo.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 |
| 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 |
Not provided
Not provided
|
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