Ruxolitinib in Treating Participants With Chronic Myeloid Leukemia With Minimal Residual Disease While on Therapy With Tyrosine Kinase Inhibitors
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT01751425
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive in Remission
- Minimal Residual Disease
- Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dasatinib — DRUGGiven PO
- Imatinib Mesylate — DRUGGiven PO
- Nilotinib — DRUGGiven PO
- Ruxolitinib — DRUGGiven PO
Study Details
This phase I/II trial studies the side effects and best dose of ruxolitinib and to see how well it works in participants with chronic myeloid leukemia with minimal residual disease while on therapy with tyrosine kinase inhibitors. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Key Dates
- Start date
- Jul 24, 2013
- Status verified
- May 2025
- Primary completion
- Sep 24, 2019
- Completion
- Sep 24, 2019
Study Design
- Enrollment
- 8 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (TKIs, ruxolitinib)Participants receive commercially available TKIs (imatinib mesylate, nilotinib, or dasatinib) as they had been receiving during the last 6 months and ruxolitinib PO BID. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Residual disease as measured by polymerase chain reaction (PCR) (Phase II) [ Time Frame: Up to 7 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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