Trial · NCT01611090
A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT01611090, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2020-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. Trials, record NCT01611090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01611090
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- NCT number
- NCT01611090
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 578 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Interventions
- Ibrutinib, Bendamustine hydrochloride, Rituximab, Placebo
- First posted
- 2012-06-04
- Last updated
- 2020-03-03
- Other registries' IDs
- eudract:2012-000600-15
- Results first posted
- 2020-03-03
- Limitations and caveats
Study was planned to end when 80% of randomized participants died or 5 years after last participant randomized, whichever was first. Sponsor terminated study on 23-Jan-2019 (5 year after last participant randomized) and study was considered completed
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to 5 years | PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); \>=50% increase in existing lymph nodes; \>=50% increase in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (and to \>=5\*10\^9/L) or \>=50% increase from nadir count confirmed on \>=2 serial assessments if absolute lymphocyte count (ALC) \>=30,000 per microliter and lymphocyte doubling time is rapid, unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b \[Hgb\] or platelets) attributable to CLL; and transformation to a more aggressive histology. |
| Secondary | Overall Response Rate (ORR) | Up to 5 years | ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils \>1.5\*10\^9/liter (L), platelets \>100\*10\^9/L, Hgb \>11 gram per deciliter (g/dL) and absolute lymphocyte count \<4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR-2 of the following when abnormal at baseline: \>=50% decrease in ALC, \>=50% decrease in sum products of up to 6 lymph nodes, \>=50% decrease in enlargement of spleen or liver; and 1 of the following: neutrophils \>1.5\*10\^9/L, Platelets \>100\*10\^9/L and Hgb\>11 g/dL or \>=50% improvement over baseline in any of these; no new enlarged nodes or new hepatosplenomegaly. |
| Secondary | Overall Survival (OS) | Up to 5 years | OS was defined as the interval between the date of randomization and the date of death from any cause. |
| Secondary | Percentage of Participants With Minimal Residual Disease (MRD)-Negative Response | Up to 5 years | MRD-negative response was defined as the percentage of participants who reach MRD negative disease status (less than 1 chronic lymphocytic leukemia \[CLL\] cell per 10,000 leukocytes) in either bone marrow or peripheral blood. All randomized participants were included in this analysis. Participants with missing MRD data were considered non-responders. |
| Secondary | Percentage of Participants With Sustained Hematologic Improvement | Up to 5 years | Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (\>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (\>)100\* 109/liter (L) if baseline less than or equal to (\<=) 100\*109/L or increase \>= 50 percent (%) over baseline; 2) Hemoglobin \>11 gram per deciliters (g/dL) if baseline \<= 11 g/dL or increase \>= 2 g/dL over baseline. |
| Secondary | Median Time to Clinically Meaningful Improvement in FACIT-Fatigue Scale | Up to 2 years | Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
| Secondary | Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms | From the date of randomization to disease progression (Up to 2 years) | The disease-related symptoms included fatigue, weight loss, fevers, night sweats, abdominal discomfort/splenomegaly and anorexia. |
| Secondary | Number of Participants Who Received Subsequent Antineoplastic Therapy | Up to 5 years | Number of participants who received subsequent antineoplastic therapy was reported. |
| Secondary | Change From Baseline in Beta2 Microglobulin at End of Treatment (EOT) | Baseline to EOT (Up to 2 years) | Change from baseline in beta2 microglobulin at end of treatment at time of primary analysis was reported. |
| Secondary | Change From Baseline in FACIT-Fatigue Scale at End of Treatment | Baseline to EOT (up to 2 years) | FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Up to 5 years | Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | Up to 5 years | Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 5 years | Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Minimal Residual Disease (MRD)-Negative Response | Up to 5 years | Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Hematologic Improvement | Up to 5 years | ITT population included all participants randomized into the study regardless of treatment actually received. | Percentage of Participants | NUMBER |
| SECONDARY | Median Time to Clinically Meaningful Improvement in FACIT-Fatigue Scale | Up to 2 years | ITT population included all participants randomized into the study regardless of treatment actually received. | Months | NUMBER |
| SECONDARY | Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms | From the date of randomization to disease progression (Up to 2 years) | ITT population included all participants randomized into the study regardless of treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Received Subsequent Antineoplastic Therapy | Up to 5 years | Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Beta2 Microglobulin at End of Treatment (EOT) | Baseline to EOT (Up to 2 years) | ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint. | milligram per liter (mg/L) | MEAN |
| SECONDARY | Change From Baseline in FACIT-Fatigue Scale at End of Treatment | Baseline to EOT (up to 2 years) | ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint. | Units on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Ibrutinib+BR | 65.12 | 95% Confidence Interval 55.43 to NA | Months | |
| Progression-free Survival (PFS) | Placebo+BR | 14.32 | 95% Confidence Interval 13.86 to 16.62 | Months | |
| Overall Response Rate (ORR) | Ibrutinib+BR | 87.2 | Percentage of participants | ||
| Overall Response Rate (ORR) | Placebo+BR | 66.1 | Percentage of participants | ||
| Overall Survival (OS) | Ibrutinib+BR | NA | 95% Confidence Interval 70.93 to NA | Months | |
| Overall Survival (OS) | Placebo+BR | NA | 95% Confidence Interval NA to NA | Months | |
| Percentage of Participants With Minimal Residual Disease (MRD)-Negative Response | Ibrutinib+BR | 28.7 | Percentage of participants | ||
| Percentage of Participants With Minimal Residual Disease (MRD)-Negative Response | Placebo+BR | 5.9 | Percentage of participants | ||
| Percentage of Participants With Sustained Hematologic Improvement | Ibrutinib+BR | Hemoglobin | 36.7 | Percentage of Participants | |
| Percentage of Participants With Sustained Hematologic Improvement | Placebo+BR | Hemoglobin | 29.1 | Percentage of Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Period | STARTED | Ibrutinib+BR | 289 | |
| Randomized Period | STARTED | Placebo+BR | 289 | |
| Randomized Period | STARTED | Crossover to Ibrutinib | 0 | |
| Randomized Period | Treated | Ibrutinib+BR | 287 | |
| Randomized Period | Treated | Placebo+BR | 287 | |
| Randomized Period | Treated | Crossover to Ibrutinib | 0 | |
| Randomized Period | COMPLETED | Ibrutinib+BR | 259 | |
| Randomized Period | COMPLETED | Placebo+BR | 260 | |
| Randomized Period | COMPLETED | Crossover to Ibrutinib | 0 | |
| Randomized Period | NOT COMPLETED | Ibrutinib+BR | 30 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,311
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 | Anaemia | Blood and lymphatic system disorders | Ibrutinib+BR | 73 | 287 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo+BR | 79 | 287 | |
| other | Anaemia | Blood and lymphatic system disorders | Crossover to Ibrutinib | 33 | 183 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ibrutinib+BR | 15 | 287 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo+BR | 18 | 287 | |
| other | Leukopenia | Blood and lymphatic system disorders | Crossover to Ibrutinib | 2 | 183 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ibrutinib+BR | 170 | 287 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo+BR | 159 | 287 | |
| other | Neutropenia | Blood and lymphatic system disorders | Crossover to Ibrutinib | 40 | 183 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ibrutinib+BR | 90 | 287 |
1 to 10 of 1,311Source ClinicalTrials.gov
See all 1,311 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibrutinib+BR | 74 | 287 |
| Total, all-cause mortality | Placebo+BR | 107 | 287 |
| Total, all-cause mortality | Crossover to Ibrutinib | 57 | 183 |
| Total, other adverse events | Ibrutinib+BR | 268 | 287 |
| Total, other adverse events | Placebo+BR | 271 | 287 |
| Total, other adverse events | Crossover to Ibrutinib | 157 | 183 |
| Total, serious adverse events | Ibrutinib+BR | 198 | 287 |
| Total, serious adverse events | Placebo+BR | 127 | 287 |
| Total, serious adverse events | Crossover to Ibrutinib | 105 | 183 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ibrutinib+BR vs Placebo+BR: Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms | Trial comparisons |
| Ibrutinib+BR vs Placebo+BR: Number of Participants Who Received Subsequent Antineoplastic Therapy | 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.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01611090/results?page=2