| Primary | Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment | CR defined as: 1) laboratory CR: peripheral blood lymphocytes (PBL) less than (<) 4000/microliter (μL), neutrophils (PMN) greater than (>) 1500/μL, platelets >100,000/μL, and hemoglobin (Hb) >11 grams per deciliter (g/dL); 2) clinical CR: lymph nodes (LN) <1.5 centimeter (cm), and no constitutional symptoms, hepatomegaly (HM) or splenomegaly (SM); 3) instrumental CR: LN <1.5 cm and no HM/SM, and 4) bone marrow (BM) CR: normocellular aspirate/biopsy for participant age <30 percent (%) lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to chronic lymphocytic leukemia (CLL), with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from baseline (BL) in the HM/SM, and 1 of the following: PMN >1500/μL, platelets >100,000/μL or >50% improvement from BL, and Hb >11.0 g/dL or >50% improvement from BL. | Intent to treat (ITT) population: all consented participants who received at least 1 dose of rituximab. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 10 | | | | ID | Title | Description |
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| OG000 | CLB + R: All Participants | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00082.4(74.25 to 90.46)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Analysis compared responders and non-responders. | Chi-squared | | 0.0008 | | | | | | 2-Sided | | | | | | | | Superiority or Other | | |
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| Secondary | Percentage of Participants With Documented CR, CRi, or PR at the End of Study | CR defined as: 1) laboratory CR: PBL <4000/μL, PMN > 1500/μL, platelets > 100,000/μL, and Hb > 11 g/dL; 2) clinical CR: LN < 1.5 cm, and no constitutional symptoms, HM or SM; 3) instrumental CR: LN < 1.5 cm and no HM/SM, and 4) bone marrow CR: normocellular aspirate/biopsy for participant age < 30% lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to CLL, with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from BL in the HM/SM, and 1 of the following: PMN > 1500/μL, platelets > 100,000/μL or > 50% improvement from BL, and Hb >11.0 g/dL or > 50% improvement from BL. | All randomized participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 35 | | | | ID | Title | Description |
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| OG000 | CLB + R: Maintenance Treatment | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months. | | OG001 |
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| Secondary | Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment | CR, CRi, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a greater than or equal to (≥) 50% increase in greatest diameter of any previously noted lesion; 2) a ≥ 50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥ 50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter's syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥ 6 months. Nodular PR was defined by the presence of residual lymphoid nodules. | | Posted | | Number | | percentage of participants | | Month 10 | | | | ID | Title | Description |
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| OG000 | CLB + R: Induction Treatment | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. |
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| Secondary | Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study | CR, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a ≥ 50% increase in greatest diameter of any previously noted lesion; 2) a ≥50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter's syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥6 months. Nodular PR was defined by the presence of residual lymphoid nodules. | All randomized participants who were assessed at Month 35 were included in the analysis. | Posted | | Number | | percentage of participants | | Month 35 | | | | ID | Title | Description |
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| OG000 | CLB + R: Maintenance Treatment | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months. | |
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| Secondary | Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment | Immunophenotypic CR was defined as the absence of minimal residual disease (MRD) evaluated in participants with CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells. Molecular CR was defined as the absence of MRD evaluated in participants with CR by quantitative polymerase chain reaction (PCR) in PB and BM B cells to confirm that tissue was comprised of non-CLL cells. | | Posted | | Number | | participants | | Month 10 | | | | ID | Title | Description |
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| OG000 | CLB + R: Induction Treatment | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. |
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| Secondary | Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study | CR, CRi, PR, SD, PD, relapse, and nodular PR as previously defined. | All randomized participants. | Posted | | Number | | percentage of participants | | Month 35 | | | | ID | Title | Description |
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| OG000 | CLB + R: Maintenance Treatment | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months. | | OG001 | CLB + R: Observation | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment. |
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| Secondary | Percentage of Participants With Immunophenotypic CR - BM or Immunophenotypic CR - PB at the End of Study | Immunophenotypic CR was defined as the absence of MRD evaluated in participants who achieved CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells. | All randomized participants, only participants with a confirmed CR were included in the analysis. | Posted | | Number | | percentage of participants | | Month 35 | | | | ID | Title | Description |
|---|
| OG000 | CLB + R: Maintenance Treatment | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months. |
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| Secondary | Percentage of Participants With Molecular CR - BM or Molecular CR - PB at the End of Study | Molecular CR was defined as the absence of MRD evaluated in participants who achieved CR by quantitative PCR in PB and BM B cells to confirm that tissue was comprised of non-CLL cells. | All randomized participants analyzed for the given parameter at the specified timepoint. | Posted | | Number | | percentage of participants | | Month 35 | | | | ID | Title | Description |
|---|
| OG000 | CLB + R: Maintenance Treatment | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months. |
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| Secondary | Number of Participants With Disease Progression, Relapse, Death, Withdrawal Because of an Adverse Event (AE), or New CLL Treatment | Event-free Survival (EFS) was defined as the time from the first dose of study treatment to the date of first documentation of disease progression, relapse for participants with previous CR, death due to any cause, withdrawal due to AE, or beginning new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose of study treatment. | | Posted | | Number | | participants | | Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
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| OG000 | CLB + R: All Participants | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment. |
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| Secondary | EFS | The median time, in days, from the the date of first dose of study treatment to the date of first documentation of disease progression, relapse for participants with CR, death due to any cause, withdrawal due to AE, or new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose if study treatment. The 95% CI was determined using Kaplan-Meier methodology. | | Posted | | Median | 95% Confidence Interval | days | | Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
|---|
| OG000 | CLB + R: All Participants | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment. |
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| Secondary | Number of Participants With Disease Progression or Death | Progression-free survival (PFS) was defined as the time from the first dose of study treatment to the first documentation of disease progression or death. PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment. | | Posted | | Number | | participants | | Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
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| OG000 | CLB + R: All Participants | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment. |
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| Secondary | PFS | The median time, in days, from the date of the first dose of study treatment to the date of first documentation of disease progression or death. CR and PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment. The 95% CI was determined using Kaplan-Meier methodology. | | Posted | | Median | 95% Confidence Interval | days | | Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
|---|
| OG000 | CLB + R: All Participants | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment. |
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| Secondary | Number of Participants With New CLL Treatment or Death | Time to new CLL treatment (TTNT) was defined as the time from the first dose of study treatment to the date of new CLL treatment received or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. | | Posted | | Number | | participants | | Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
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| OG000 | CLB + R: All Participants | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment. |
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| Secondary | Time to Next Treatment (TTNT) | The mean time, in days, from the date of the first dose of study treatment to the date of new CLL treatment or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. Mean survival time and it's standard error (SE) were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | | Posted | | Mean | Standard Error | days | | Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
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| OG000 | CLB + R: All Participants | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment. |
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| Secondary | Number of Participants Who Died | Overall Survival (OS) was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. | | Posted | | Number | | participants | | Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
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| OG000 | CLB + R: All Participants | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment. |
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| Secondary | OS | The mean time, in days, from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. The mean survival time and it's SE were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. | | Posted | | Mean | Standard Error | days | | Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
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| OG000 | CLB + R: All Participants | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment. |
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| Secondary | Number of Participants With PD or Death After a Confirmed CR, CRi, or PR | Duration of response was defined as the time from the date of the first documented CR, CRi, or PR to the date of disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively. | All randomized participants. | Posted | | Number | | participants | | Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
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| OG000 | CLB + R: Maintenance Treatment | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months. | | OG001 | CLB + R: Observation | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment. |
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| Secondary | Duration of Response | The mean time, in days, from the date of first documented CR, CRi or PR to the date disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively. | All randomized participants. | Posted | | Mean | Standard Error | days | | Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
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| OG000 | CLB + R: Maintenance Treatment | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months. | | OG001 | CLB + R: Observation | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment. |
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| Secondary | Number of Participants With PD or Death After a Confirmed CR/CRi | Disease-free survival was defined at the time from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi. | All randomized participants with a confirmed CR or CRi were included in the analysis. | Posted | | Number | | participants | | Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
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| OG000 | CLB + R: Maintenance Treatment | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months. | | OG001 | CLB + R: Observation | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment. |
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| Secondary | Disease-Free Survival | The mean time, in days, from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi. In both groups, 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. | All randomized participants. | Posted | | Mean | Standard Error | days | | Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months. | | | | ID | Title | Description |
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| OG000 | CLB + R: Maintenance Treatment | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months. | | OG001 | CLB + R: Observation | Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment. |
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