Ruxolitinib Phosphate and Azacytidine in Treating Patients With Myelofibrosis or Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01787487
Phase
PHASE2
Status
Completed

Conditions

  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Myelofibrosis Transformation in Essential Thrombocythemia
  • Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Given SC or IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Ruxolitinib Phosphate — DRUG
    Given PO

Study Details

This phase II trial studies how well ruxolitinib phosphate and azacytidine work in treating patients with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacytidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ruxolitinib phosphate and azacytidine may be an effective treatment for myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm.

Key Dates

Start date
Mar 13, 2013
Status verified
Mar 2026
Primary completion
Jan 20, 2026
Completion
Jan 20, 2026

Study Design

Enrollment
121 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (MF patients)
    Patients with MF receive ruxolitinib phosphate PO BID on days 1-28. Beginning course 4, patients also receive azacytidine SC or IV for 5 days. Treatment repeats every 28 days for 15 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (MDS/MPN patients)
    Patients with MDS/MPN receive ruxolitinib phosphate and azacytidine as in Arm I.

Primary Outcome Measure

Objective response rate (complete remission, partial remission, clinical improvement) in patients with myelofibrosis [ Time Frame: Up to 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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