Phase l/II Study of Ruxolitinib for Acute Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01251965
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    Phase I - Starting dose of 50 mg by mouth twice a day for 28 day cycle. Phase II - MTD reached in Phase I.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of ruxolitinib that can be given to patients with acute leukemia and to learn if the study drug can help control the disease. The safety of the drug will also be studied.

Key Dates

Start date
Dec 31, 2010
Status verified
May 2025
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

Enrollment
27 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib 50 mg BID
    Phase I - Starting dose of Ruxolitinib 50 mg by mouth twice a day for 28 day cycle.
  • Experimental: Ruxolitinib 100 mg BID
    Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
  • Experimental: Ruxolitinib 200 mg BID
    Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: End of first 28 day cycle for toxicity ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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