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NCT03478514 · ClinicalTrials.gov registry record · Phase 2
Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma
A Phase 2 study of Mantle Cell Lymphoma and B-cell Lymphoma, sponsored by Alliance Foundation Trials.
- Active
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 9
- Study locations
NCT03478514: Active Phase 2 study of Mantle Cell Lymphoma and B-cell Lymphoma, sponsored by Alliance Foundation Trials.
NCT03478514 is a Phase 2 study of Mantle Cell Lymphoma and B-cell Lymphoma that is active but no longer recruiting, run by Alliance Foundation Trials. The registered enrollment target is 39 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (62% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03478514, a Phase 2 study of Mantle Cell Lymphoma and B-cell Lymphoma, is active but no longer recruiting, sponsored by Alliance Foundation Trials.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 9
- Study locations
Study Summary
The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma to evaluate the efficacy of this combination, with the primary objective of the study being to assess median PFS and the secondary objectives to include ORR, CR, DOR, OS and toxicity. Subjects will be enrolled and treated with palbociclib and ibrutinib with each cycle of therapy being 28 days. Treatment will be based on the recommended phase II dose (RP2D) from the phase I combination trial.
Primary Outcome
Time interval between registration and progression or death
Conditions Studied
Interventions
- DRUG Palbociclib
- DRUG Ibrutinib
Study Locations (9)
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Weill Cornell Medical College - New York
California
- City of Hope National Medical Center - Duarte
Maryland
- University of Maryland, Greenebaum Comprehensive Cancer Center - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- St. Joseph Mercy Hospital Cancer Care Center - Ypsilanti
North Carolina
- University of North Carolina - Chapel Hill
Ohio
- Ohio State University - Columbus
South Carolina
- Medical University of South Carolina - Hollings Cancer Center - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-09-11 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 2 |
What the registry record for NCT03478514 still lists
NCT03478514 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (62% lower).
The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Palbociclib is the first listed.
NCT03478514 lists 9 locations in 8 states (New York, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT03478514 about?
NCT03478514 is a clinical study titled "Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma". The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma to evaluate the efficacy of this combination, with the primary objective of the study being to assess median PFS and th...
What is the current status of trial NCT03478514?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2018-09-11. Estimated completion is 2026-03-30.
What conditions does trial NCT03478514 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, B-cell Lymphoma.
What interventions are being tested in trial NCT03478514?
The interventions under investigation include: Palbociclib (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT03478514?
This trial is sponsored by Alliance Foundation Trials, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03478514 being conducted?
This trial has 9 study locations across California, Maryland, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mantle Cell Lymphoma
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Where NCT03478514's enrollment target sits among peer trials
39 56th of 102 higher than 45 of 102 other Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell Lymphoma 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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