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NCT02251548 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Ibrutinib Plus FCR in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia
A Phase 2 study of Leukemia and Chronic Lymphocytic Leukemia, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
- 9
- Study locations
NCT02251548: Active Phase 2 study of Leukemia and Chronic Lymphocytic Leukemia, sponsored by Dana-Farber Cancer Institute.
NCT02251548 is a Phase 2 study of Leukemia and Chronic Lymphocytic Leukemia that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 85 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (83% lower). The trial reports 9 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02251548, a Phase 2 study of Leukemia and Chronic Lymphocytic Leukemia, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
- 9
- Study locations
Study Summary
This research study is evaluating a new drug called ibrutinib in combination with the standard drugs fludarabine, cyclophosphamide, and rituximab (FCR) as a possible treatment for Chronic Lymphocytic Leukemia (CLL).
Primary Outcome
To assess the number of participants who achieve an MRD negative complete response at the 2 months post last dose of FCR timepoint by 2008 IW-CLL criteria ( Hallek et. al). Participants will have a bone marrow biopsy procedure 2 months after completing combination therapy (Ibrutinib+ FCR) in tandem with a chest, neck, abdomen and pelvic PET CT scan. A central read of the PET CT scan will confirm a radiographic complete response, and the bone marrow pathology and morphology assessments will confi
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- DRUG Ibrutinib
Study Locations (9)
Florida
- University of Miami Sylvester Comprehensive Cancer Center - Coral Gables
- University of Miami Sylvester Comprehensive Cancer Center - Deerfield Beach
- Unversity of Miami Sylvester Comprehensve Cancer Center - Miami
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana Farber Cancer Institute - Boston
Kansas
- University of Kansas Cancer Center - Westwood
Michigan
- West Michigan Cancer Center - Kalamazoo
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2014-10 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What the registry record for NCT02251548 still lists
NCT02251548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02251548 lists 9 locations in 5 states (Florida, Massachusetts, Kansas).
Frequently Asked Questions
What is clinical trial NCT02251548 about?
NCT02251548 is a clinical study titled "A Phase II Study of Ibrutinib Plus FCR in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia". This research study is evaluating a new drug called ibrutinib in combination with the standard drugs fludarabine, cyclophosphamide, and rituximab (FCR) as a possible treatment for Chronic Lymphocytic Leukemia (CLL).
What is the current status of trial NCT02251548?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2014-10. Estimated completion is 2027-01.
What conditions does trial NCT02251548 study?
This clinical trial studies the following conditions: Leukemia, Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT02251548?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02251548?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02251548 being conducted?
This trial has 9 study locations across Florida, Kansas, Massachusetts, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02251548's enrollment target sits among peer trials
85 76th of 233 higher than 158 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia 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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