Trial · NCT02420912
Nivolumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or High-Risk Untreated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Richter Transformation
NCT02420912, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2024-03-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nivolumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or High-Risk Untreated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Richter Transformation. Trials, record NCT02420912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02420912
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or High-Risk Untreated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Richter Transformation
- NCT number
- NCT02420912
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Loss of Chromosome 17p, Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma, Richter Syndrome
- Interventions
- Ibrutinib, Laboratory Biomarker Analysis, Nivolumab
- First posted
- 2015-04-20
- Last updated
- 2024-03-20
- Results first posted
- 2024-03-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Response for Cohorts 1 and 3 | Up to 12 months | Response is Complete Response (CR) + Partial Response (PR). CR = Peripheral blood Lymphocytes \<4000/uL, no lymphadenopathy, no hepatomegaly or splenomegaly by exam or scan, absence of symptoms, neutrophils \> 1,500/uL, Platelets \> 1000,000/uL, hemoglobin \> 11.0 g/dl (untransfused) and normocellular bone marrow \< 30% nucleated cells being lymphocytes, no lymphoid nodules. PR = 1 for \>/= 2 months: \>/= 50% decrease in peripheral lymphocyte count from baseline, \>/= 50% reduction in lymphadenopathy, \>/= 50% reduction in pretreatment enlargement of the spleen or liver by scan. Additionally for PR must have 1 of the following for \>/= 2 months: Neutrophils \> 1,500/uL, Platelets \> 100,000/uL or \>/= 50% improvement over baseline or Hemoglobin \> 11.0 g/dl (untransfused) or \>/= 50% improvement over baseline. Additionally if patients fufill CR but have one of the following, be considered a PR: bone marrow nodules or persistent anemia, thrombocytopenia, neutropenia unrelated to disease. |
| Primary | Number of Participants in Cohort 2 to Convert From a Partial Response (PR) to Complete Response (CR) | Up to 12 months | Complete Response (CR) = Peripheral blood Lymphocytes \<4000/uL, no lymphadenopathy, no hepatomegaly or splenomegaly by exam or scan, absence of symptoms, neutrophils \> 1,500/uL, Platelets \> 1000,000/uL, hemoglobin \> 11.0 g/dl (untransfused) and normocellular bone marrow \< 30% nucleated cells being lymphocytes, no lymphoid nodules. Partial Response (PR) = 1 for \>/= 2 months: \>/= 50% decrease in peripheral lymphocyte count from baseline, \>/= 50% reduction in lymphadenopathy, \>/= 50% reduction in pretreatment enlargement of the spleen or liver by scan. Additionally for PR must have 1 of the following for \>/= 2 months: Neutrophils \> 1,500/uL, Platelets \> 100,000/uL or \>/= 50% improvement over baseline or Hemoglobin \> 11.0 g/dl (untransfused) or \>/= 50% improvement over baseline. Additionally if patients fufill CR but have one of the following, be considered a PR: bone marrow nodules or persistent anemia, thrombocytopenia, neutropenia unrelated to disease. |
| Secondary | Overall Survival (OS) | Up to 6 years, 7 months | Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be presented by median survival, which is the time point at which the cumulative survival drops below 50%. If there is no median survival (not reached), it means the cumulative survival was more than 50%. |
| Secondary | Progression-free Survival (PFS) | Up to 6 years, 7 months | Time from date of treatment start until the date of first objective documentation of disease-relapse. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Response for Cohorts 1 and 3 | Up to 12 months | This outcome measure was only designed for those participants in cohort 1 and 3. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants in Cohort 2 to Convert From a Partial Response (PR) to Complete Response (CR) | Up to 12 months | This outcome measure was designed for participants from Cohort 2, already on ibrutinib treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | Up to 6 years, 7 months | Two participants in Cohort 3 were not evaluable for response. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Up to 6 years, 7 months | Two participants in Cohort 3 were not evaluable for response. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Response for Cohorts 1 and 3 | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 5 | Participants | ||
| Number of Participants With a Response for Cohorts 1 and 3 | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | 10 | Participants | ||
| Number of Participants in Cohort 2 to Convert From a Partial Response (PR) to Complete Response (CR) | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 1 | Participants | ||
| Overall Survival (OS) | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | NA | Full Range 8.2 to 79.0 | months | |
| Overall Survival (OS) | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | NA | Full Range 78.0 to 79.0 | months | |
| Overall Survival (OS) | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | NA | Full Range 1 to 19 | months | |
| Progression-free Survival (PFS) | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 50.1 | Full Range 4.6 to 79.0 | Months | |
| Progression-free Survival (PFS) | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 22.3 | Full Range 7.8 to 46.7 | Months | |
| Progression-free Survival (PFS) | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | 15 | Full Range 3.5 to 17.5 | Months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 7 | |
| Overall Study | STARTED | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 3 | |
| Overall Study | STARTED | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | 26 | |
| Overall Study | COMPLETED | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 7 | |
| Overall Study | COMPLETED | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 3 | |
| Overall Study | COMPLETED | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | 26 | |
| Overall Study | NOT COMPLETED | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 0 | |
| Overall Study | NOT COMPLETED | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 0 | |
| Overall Study | NOT COMPLETED | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | 0 |
Source ClinicalTrials.gov
Adverse events231
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 | Alanine aminotransferase increased | Investigations | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 1 | 7 | 1 |
| other | Alanine aminotransferase increased | Investigations | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 0 | 3 | 0 |
| other | Alanine aminotransferase increased | Investigations | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | 0 | 26 | 0 |
| other | Acute Otitis Media | Ear and labyrinth disorders | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 0 | 7 | 0 |
| other | Acute Otitis Media | Ear and labyrinth disorders | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 0 | 3 | 0 |
| other | Acute Otitis Media | Ear and labyrinth disorders | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | 2 | 26 | 2 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 1 | 7 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 1 | 3 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | 0 | 26 | 0 |
| other | Anorexia | Gastrointestinal disorders | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 1 | 7 | 1 |
1 to 10 of 231Source ClinicalTrials.gov
See all 231 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 3 | 7 |
| Total, all-cause mortality | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 0 | 3 |
| Total, all-cause mortality | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | 13 | 26 |
| Total, other adverse events | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 7 | 7 |
| Total, other adverse events | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 3 | 3 |
| Total, other adverse events | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | 19 | 26 |
| Total, serious adverse events | Cohort I (Nivolumab, Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 3 | 7 |
| Total, serious adverse events | Cohort II (Nivolumab, Previous Ibrutinib) Chronic Lymphocytic Leukemia (CLL) | 1 | 3 |
| Total, serious adverse events | Cohort III (Nivolumab, Ibrutinib) Richters Transformation (RT) | 15 | 26 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36287248 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT02420912
GET https://conductscience.org/api/trials/v1/NCT02420912/events?page=2