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NCT03610971 · ClinicalTrials.gov registry record · Phase 2
Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors
A Phase 2 study of Chronic Myeloid Leukemia, Chronic Phase and Chronic Phase Chronic Myeloid Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 8
- Study locations
NCT03610971: Active Phase 2 study of Chronic Myeloid Leukemia, Chronic Phase and Chronic Phase Chronic Myeloid Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03610971 is a Phase 2 study of Chronic Myeloid Leukemia, Chronic Phase and Chronic Phase Chronic Myeloid Leukemia that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 24 participants, below the 108-participant average among 3 other Chronic Myeloid Leukemia, Chronic Phase trials with a reported enrollment target (78% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03610971, a Phase 2 study of Chronic Myeloid Leukemia, Chronic Phase and Chronic Phase Chronic Myeloid Leukemia, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to determine if adding Ruxolitinib to a Tyrone Kinase Inhibitor (TKI), prior to a second attempt at stopping a TKI will lead to prolonged treatment free remission (TFR).
Primary Outcome
TFR rate after completion of 12 cycles of combination therapy.
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG BCR-ABL Tyrosine Kinase Inhibitor (TKI)
Study Locations (8)
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering - New York
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Georgia
- Emory -Winship Cancer Institute - Atlanta
New Jersey
- Memorial Sloan Kettering - Bergen - Montvale
North Carolina
- Duke University Hospital - Durham
Oregon
- Oregon Health & Science University - Portland
Wisconsin
- Froedtert Hospital & the Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What the registry record for NCT03610971 still lists
NCT03610971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 108-participant average among 3 other Chronic Myeloid Leukemia, Chronic Phase trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Chronic Myeloid Leukemia, Chronic Phase appearing as the primary indexed condition, and to 2 interventions - of which Ruxolitinib is the first listed.
NCT03610971 lists 8 locations in 7 states (New York, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT03610971 about?
NCT03610971 is a clinical study titled "Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors". The purpose of this study is to determine if adding Ruxolitinib to a Tyrone Kinase Inhibitor (TKI), prior to a second attempt at stopping a TKI will lead to prolonged treatment free remission (TFR).
What is the current status of trial NCT03610971?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2019-11-19. Estimated completion is 2026-10.
What conditions does trial NCT03610971 study?
This clinical trial studies the following conditions: Chronic Myeloid Leukemia, Chronic Phase, Chronic Phase Chronic Myeloid Leukemia.
What interventions are being tested in trial NCT03610971?
The interventions under investigation include: Ruxolitinib (DRUG), BCR-ABL Tyrosine Kinase Inhibitor (TKI) (DRUG).
Who is sponsoring clinical trial NCT03610971?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03610971 being conducted?
This trial has 8 study locations across Florida, Georgia, New Jersey, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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