Study of Combination Ruxolitinib and Decitabine Treatment for Accelerated Phase MPN or Post-MPN AML

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

July 20, 2018

Study Completion Date

July 20, 2018

Conditions
Myeloproliferative Neoplasms
Interventions
DRUG

Ruxolitinib

Ruxolitinib will be administered at doses of 5mg, 10mg, 15mg, or 25 mg taken orally every 12 hours throughout the treatment cycle.

DRUG

Decitabine

Decitabine is administered intravenously at a dose of 20 mg/m2 daily for 5 days. Subsequent cycles of decitabine may be administered at 4 week intervals as clinically tolerated. Decitabine treatment may be deferred for up to 2 weeks to allow recovery from non-hematologic toxicity during the first 6 cycles and up to 2 weeks thereafter for hematologic toxicities as well. The first treatment cycle will last 35 days and will be the evaluable period for DLTs and RPTD determination for patients enrolled in the phase I portion only. Subsequent treatment cycles will be 4-6 weeks in duration as defined by decitabine administration.

Trial Locations (8)

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Medical Center, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

14263

Roswell Park Cancer Institute, Buffalo

19104

University of Pennsylvania, Philadelphia

27157

Wake Forest University Baptist Medical Center, Winston-Salem

44195

Cleveland Clinic Taussig Cancer Center Institute, Cleveland

63110

Washington University of St. Louis, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Myeloproliferative Disorders-Research Consortium

NETWORK

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Incyte Corporation

INDUSTRY

lead

John Mascarenhas

OTHER