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NCT02420912 · ClinicalTrials.gov registry record · Phase 2
Nivolumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or High-Risk Untreated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Richter Transformation
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT02420912: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02420912 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02420912, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
This phase II trial studies how well nivolumab and ibrutinib work when given together in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or Richter transformation that has come back after a period of improvement (relapsed), does not respond to treatment (refractory), or is at high risk of spreading and has not been treated. Immunotherapy with monoclonal antibodies, such as niolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving nivolumab together with ibrutinib may kill more cancer cells.
Primary Outcome
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 lymphadeno
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2015-06-19 |
| Est. Completion | 2022-02-14 |
| Phase | Phase 2 |
What the finished NCT02420912 record still lists
NCT02420912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02420912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02420912 about?
NCT02420912 is a clinical study titled "Nivolumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or High-Risk Untreated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Richter Transformation". This phase II trial studies how well nivolumab and ibrutinib work when given together in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or Richter transformation that has come back after a period of improvement (relapsed), does not respond to treatment (refractory),...
What is the current status of trial NCT02420912?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2015-06-19. Estimated completion is 2022-02-14.
What interventions are being tested in trial NCT02420912?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02420912?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02420912's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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