Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors
NCT03610971 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-04-02
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).
Conditions
- Chronic Phase Chronic Myeloid Leukemia
- Chronic Myeloid Leukemia, Chronic Phase
Interventions
- DRUG
-
Ruxolitinib: 15 mg by mouth (PO) twice a day (BID).
- DRUG
-
BCR-ABL Tyrosine Kinase Inhibitor (TKI)
The BCR-ABL TKIs that will be used include imatinib, dasatinib, nilotinib or bosutinib.
Sponsors & Collaborators
-
H. Jean Khoury Cure CML Consortium
collaborator OTHER - collaborator INDUSTRY
-
H. Lee Moffitt Cancer Center and Research Institute
lead OTHER
Principal Investigators
-
Javier Pinilla-Ibarz, MD, PhD · H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-19
- Primary Completion
- 2025-09-25
- Completion
- 2026-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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