Trial · NCT01056510
A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)
NCT01056510, Phase 4, Completed, Hoffmann-La Roche; results first posted 2015-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe). Trials, record NCT01056510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01056510
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)
- NCT number
- NCT01056510
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 357 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- bendamustine, chlorambucil, rituximab [MabThera/Rituxan]
- First posted
- 2010-01-26
- Last updated
- 2015-06-25
- Results first posted
- 2015-06-25
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy | At least 2 months after completion of therapy (up to 32 weeks) | The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes less than (\<) 4 times 10\^9 cells per liter (cells/L); absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to chronic lymphocytic leukemia (CLL) involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils at least (\>/=) 1.5 times 10\^9 cells/L, platelets greater than (\>) 100 times 10\^9 cells/L, and hemoglobin \> 11.0 grams per deciliter (g/dL); normocellular bone marrow (BM) aspirate with \< 30 percent (%) lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. |
| Secondary | Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy | At least 2 months after completion of therapy (up to 32 weeks) | The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes \< 4 times 10\^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils \>/= 1.5 times 10\^9 cells/L, platelets \> 100 times 10\^9 cells/L, and hemoglobin \> 11.0 g/dL; normocellular BM aspirate with \< 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. |
| Secondary | Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Second-Line Subpopulation After 6 Cycles of Therapy | At least 2 months after completion of therapy (up to 32 weeks) | The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes \< 4 times 10\^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils \>/= 1.5 times 10\^9 cells/L, platelets \> 100 times 10\^9 cells/L, and hemoglobin \> 11.0 g/dL; normocellular BM aspirate with \< 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. |
| Secondary | Percentage of Participants Achieving a Best Overall Response of CR, CR With Incomplete Marrow Recovery (CRi), Partial Response (PR), or Nodular PR (nPR) in the First-Line Subpopulation | After 3 and 6 treatment cycles and from Baseline to the end-of-treatment (EOT) visit, completed within 10 days before cutoff for data collection | The criteria for CR are identified in previous outcome measure(s). Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi. The definition of PR required that the following be documented for minimum 2 months: \>/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; \>/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes \>/= 1.5 times 10\^9 cells/L, platelets \> 100 times 10\^9 cells/L or \>/= 50% improvement from Baseline, or hemoglobin \> 11.0 g/dL or \>/= 50% improvement from Baseline. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. |
| Secondary | Percentage of Participants by Disease Response Category in the First-Line Subpopulation | After 6 treatment cycles and at the confirmation of response assessment at least 12 weeks later (up to 36 weeks) | The criteria for CR, CRi, PR, and nPR are identified in previous outcome measure(s). PD was defined by at least one of the following: the presence of lymphadenopathy; an increase in the previously noted enlargement of the liver or spleen by \>/= 50% or the de novo appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by \>/= 50% with \>/= 5000 B-cells per microliter (B-cells/mcL); transformation to a more aggressive histology; or occurrence of cytopenia attributable to CLL. Participants not achieving a CR or PR, and who did not exhibit PD, were considered to have stable disease (SD). The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed. The rows below are labeled first by the level of response at the end of 6 cycles (C6), then by level of response at the confirmation assessment. |
| Secondary | Percentage of Participants Experiencing PD or Death in the First-Line Subpopulation | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) | The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. |
| Secondary | Progression-Free Survival (PFS) in the First-Line Subpopulation | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) | The criteria for PD are identified in previous outcome measure(s). PFS was defined as the time from the first dose of trial treatment to the first documentation of PD or death, whichever occurred first. PFS was calculated in months as \[first event date minus first dose date plus 1\] divided by 30.44. |
| Secondary | Percentage of Participants With Tumor Response of CR or CRi Experiencing PD or Death in the First-Line Subpopulation | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) | The criteria for CR, CRi, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. |
| Secondary | Disease-Free Survival (DFS) in the First-Line Subpopulation | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) | The criteria for CR, CRi, and PD are identified in previous outcome measure(s). DFS was defined as the time from the first assessment of CR or CRi to the first documentation of PD or death, whichever occurred first. DFS was calculated in months as \[first event date minus first assessment date of CR/CRi plus 1\] divided by 30.44. |
| Secondary | Percentage of Participants Experiencing PD, Documented Intake of New Leukemia Therapy, or Death in the First-Line Subpopulation | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) | The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD, intake of new (post-trial) leukemia therapy, or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy | At least 2 months after completion of therapy (up to 32 weeks) | ITT Population (First-Line Subpopulation): A subset of participants requiring a first-line regimen for CLL. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy | At least 2 months after completion of therapy (up to 32 weeks) | ITT Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Second-Line Subpopulation After 6 Cycles of Therapy | At least 2 months after completion of therapy (up to 32 weeks) | ITT Population (Second-Line Subpopulation): A subset of participants requiring a second-line regimen for CLL. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Best Overall Response of CR, CR With Incomplete Marrow Recovery (CRi), Partial Response (PR), or Nodular PR (nPR) in the First-Line Subpopulation | After 3 and 6 treatment cycles and from Baseline to the end-of-treatment (EOT) visit, completed within 10 days before cutoff for data collection | ITT Population (First-Line Subpopulation) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants by Disease Response Category in the First-Line Subpopulation | After 6 treatment cycles and at the confirmation of response assessment at least 12 weeks later (up to 36 weeks) | ITT Population (First-Line Subpopulation) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing PD or Death in the First-Line Subpopulation | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) | ITT Population (First-Line Subpopulation) | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) in the First-Line Subpopulation | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) | ITT Population (First-Line Subpopulation) | months | MEDIAN |
| SECONDARY | Percentage of Participants With Tumor Response of CR or CRi Experiencing PD or Death in the First-Line Subpopulation | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) | ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Disease-Free Survival (DFS) in the First-Line Subpopulation | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) | ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis. | months | MEDIAN |
| SECONDARY | Percentage of Participants Experiencing PD, Documented Intake of New Leukemia Therapy, or Death in the First-Line Subpopulation | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) | ITT Population (First-Line Subpopulation) | percentage of participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group128
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy | Rituximab + Bendamustine | Confirmed CR with biopsy | 24 | percentage of participants | |
Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy | Rituximab + Chlorambucil | Confirmed CR with biopsy | 9.2 | percentage of participants | |
Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy | Rituximab + Bendamustine | CR without biopsy | 2.5 | percentage of participants | |
Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy | Rituximab + Chlorambucil | CR without biopsy | 5.8 | percentage of participants | |
Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy | Rituximab + Bendamustine | No confirmed CR | 73.6 | percentage of participants | |
Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy | Rituximab + Chlorambucil | No confirmed CR | 85 | percentage of participants | |
| Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy | Rituximab + Bendamustine | Confirmed CR with biopsy | 21.3 | percentage of participants | |
| Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy | Rituximab + Chlorambucil | Confirmed CR with biopsy | 6.7 | percentage of participants | |
| Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy | Rituximab + Bendamustine | CR without biopsy | 2.8 | percentage of participants | |
| Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy | Rituximab + Chlorambucil | CR without biopsy | 4.5 | percentage of participants |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab + Bendamustine | 178 | |
| Overall Study | STARTED | Rituximab + Chlorambucil | 179 | |
| Overall Study | COMPLETED | Rituximab + Bendamustine | 124 | |
| Overall Study | COMPLETED | Rituximab + Chlorambucil | 115 | |
| Overall Study | NOT COMPLETED | Rituximab + Bendamustine | 54 | |
| Overall Study | NOT COMPLETED | Rituximab + Chlorambucil | 64 |
Source ClinicalTrials.gov
Adverse events290
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab + Bendamustine | 97 | 177 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab + Chlorambucil | 86 | 178 | |
| other | Leukopenia | Blood and lymphatic system disorders | Rituximab + Bendamustine | 42 | 177 | |
| other | Leukopenia | Blood and lymphatic system disorders | Rituximab + Chlorambucil | 31 | 178 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab + Bendamustine | 35 | 177 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab + Chlorambucil | 41 | 178 | |
| other | Anaemia | Blood and lymphatic system disorders | Rituximab + Bendamustine | 40 | 177 | |
| other | Anaemia | Blood and lymphatic system disorders | Rituximab + Chlorambucil | 27 | 178 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Rituximab + Bendamustine | 30 | 177 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Rituximab + Chlorambucil | 21 | 178 |
1 to 10 of 290Source ClinicalTrials.gov
See all 290 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab + Bendamustine | ||
| Total, all-cause mortality | Rituximab + Chlorambucil | ||
| Total, other adverse events | Rituximab + Bendamustine | 165 | 177 |
| Total, other adverse events | Rituximab + Chlorambucil | 159 | 178 |
| Total, serious adverse events | Rituximab + Bendamustine | 73 | 177 |
| Total, serious adverse events | Rituximab + Chlorambucil | 56 | 178 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rituximab + Bendamustine vs Rituximab + Chlorambucil: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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