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NCT02329847 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
NCT02329847: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02329847 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 144 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (140% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02329847, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and to establish the recommended phase 2 dose (RP2D) for the combination of ibrutinib and nivolumab in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular cell lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Once the dose is optimized, the combination will be assessed for Pharmacokinetics, Pharmacodynamics, and preliminary efficacy, further safety in participants with CLL/SLL, FL or DLBCL and in participants with Richter syndrome.
Primary Outcome
ORR is percentage of participants achieving a complete response (CR), CR with incomplete marrow recovery (CRi), nodular partial response (nPR) or PR. IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils \>1.5\*10\^9/L, platelets \>100\*10\^9/L, Hgb \>11 g/dL and absolute lymphocyte count \<4000/mcL; CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, ma
Interventions
- DRUG Nivolumab
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2015-03-11 |
| Est. Completion | 2022-02-09 |
| Phase | Phase 1 |
What the finished NCT02329847 record still lists
NCT02329847 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (140% higher).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT02329847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02329847 about?
NCT02329847 is a clinical study titled "A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies". The purpose of this study is to determine the safety and to establish the recommended phase 2 dose (RP2D) for the combination of ibrutinib and nivolumab in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular cell lymphoma (FL) and diffuse large B-cell ly...
What is the current status of trial NCT02329847?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2015-03-11. Estimated completion is 2022-02-09.
What interventions are being tested in trial NCT02329847?
The interventions under investigation include: Nivolumab (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02329847?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02329847's enrollment target sits among peer trials
144 394th of 2000 higher than 1,600 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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