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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
John Mascarenhas
Study ID
NCT02076191
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Myeloproliferative Neoplasms

Eligibility Criteria

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

Interventions

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

Study Details

The purpose of this study is to test the safety and tolerability of ruxolitinib at different dose levels in combination with decitabine and the effectiveness of ruxolitinib in combination with decitabine in patients with accelerated or blast phase Myeloproliferative Neoplasm (MPN), which is a group of diseases of the bone marrow in which excess cells are produced. Ruxolitinib is a drug that is approved by the Federal Drug Administration (FDA) for the treatment of patients with advanced forms of myelofibrosis. It inhibits the Jak proteins that are often abnormal in MPN. A recent clinical study showed that ruxolitinib treatment could put some patients with this disease into remission. Decitabine is a chemotherapy, approved by the Federal Drug Administration (FDA), that has been used to treat acute leukemia. It works in some patients, but most patients with accelerated and blastic MPN do not respond to treatment. Ruxolitinib and decitabine will be combined in this study to find out what dose of the two medicines are safe together. Using Ruxolitinib in combination with Decitabine is experimental. The investigators want to find out what effects, good and/or bad it has on the patient and the disease.

Key Dates

Start date
Feb 28, 2014
Status verified
Feb 2019
Primary completion
Jul 20, 2018
Completion
Jul 20, 2018

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Myeloproliferative neoplasms
    In phase I, increasing doses of ruxolitinib in combination with decitabine at a dose of 20 mg/m2 daily intravenously over 5 days. An initial dose of ruxolitinib of 10 mg orally twice daily is anticipated with planned, dose escalations of 15 mg orally twice daily, 25 mg orally twice daily and 50 mg orally twice daily. The dose can also be de-escalated to 5mg orally twice daily if dose limiting toxicities (DLTs) are observed at the initial 10mg dose. Patients will receive ruxolitinib as a single agent for the first 7 days followed by the administration of decitabine on day 8 for a total of 5 consecutive days. Patients will continue ruxolitinib at the assigned dose through the first cycle and may reduce the dose for specified toxicity beginning with the second cycle. Patients in Phase II will start at the recommended phase II dose (RPTD) of ruxolitinib in combination with decitabine at a dose of 20 mg/m2 daily intravenously over 5 days.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: up to 5 weeks ]

Locations (8)

FacilityCityStateZIPSite coordinators
Washington University of St. LouisSt LouisMissouri63110-
Roswell Park Cancer InstituteBuffaloNew York14263-
Columbia University Medical CenterNew YorkNew York10032-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Wake Forest University Baptist Medical CenterWinston-SalemNorth Carolina27157-
Cleveland Clinic Taussig Cancer Center InstituteClevelandOhio44195-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in St Louis, MO

By research site
Washington University of St. Louis· St Louis, MORoswell Park Cancer Institute· Buffalo, NYColumbia University Medical Center· New York, NYIcahn School of Medicine at Mount Sinai· New York, NYMemorial Sloan-Kettering Cancer Center· New York, NYWake Forest University Baptist Medical Center· Winston-Salem, NC

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