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 — DRUG
    Given PO
  • Imatinib Mesylate — DRUG
    Given PO
  • Nilotinib — DRUG
    Given PO
  • Ruxolitinib — DRUG
    Given 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)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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