Ruxolitinib Prior to Transplant in Patients With Myelofibrosis

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
John Mascarenhas
Study ID
NCT01790295
Phase
PHASE2
Status
Terminated

Conditions

  • Post Essential Thrombocythemia Myelofibrosis
  • Post Polycythemia Vera Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) — DRUG
    Ruxolitinib (INC424) tablets will be started 60 days (day -65) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib will be determined according to baseline platelet count and will be modified according to platelet count at follow-up. The drug will be given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and will be stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug will be supplied as 5 mg tablets.

Study Details

The purpose of this study is to find out if giving the study drug Ruxolitinib (INC424) prior to a combination of other chemotherapeutic drugs (Fludarabine and Busulfan) before infusing another person's hematopoietic stem cells (bone marrow transplantation) will be successful in people who have advanced primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF), collectively known as myelofibrosis (MF). MF is a disorder in which bone marrow tissue develops in abnormal sites because the bone marrow itself undergoes fibrosis or scarring. This study plans to evaluate whether adding the drug Ruxolitinib will further aid in reducing pre-transplant spleen size, improve physical performance levels and reduce adverse events (side effects) related to the transplant. Ruxolitinib is a drug that is approved by the FDA for the treatment of patients with advanced forms of myelofibrosis. Using Ruxolitinib prior to stem cell transplantation is experimental.

Key Dates

Start date
Nov 30, 2013
Status verified
Feb 2019
Primary completion
Oct 26, 2017
Completion
Oct 26, 2017

Study Design

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

Arms

  • Experimental: Ruxolitinib Pre- Hematopoietic cell transplantation (HCT)
    Ruxolitinib (INC424) tablets will be started 62 days (day -67) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib will be determined according to baseline platelet count and will be modified according to platelet count at follow-up. The drug will be given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and will be stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug will be supplied as 5 mg tablets.

Primary Outcome Measure

Percent of Participants With 100-day Survival Without Graft Failure [ Time Frame: Day 100-post allogeneic stem cell transplantation ]

Locations (6)

FacilityCityStateZIPSite coordinators
Emory HospitalAtlantaGeorgia30322-
Northwestern University, Robert h. Lurie Comprehensive Cancer CenterChicagoIllinois60611-
University of Kansas Cancer CenterWestwoodKansas66205-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27103-
Ohio State UniversityColumbusOhio43210-

Find similar trials in Atlanta, GA

By research site
Emory Hospital· Atlanta, GANorthwestern University, Robert h. Lurie Comprehensive Cancer Center· Chicago, ILUniversity of Kansas Cancer Center· Westwood, KSIcahn School of Medicine at Mount Sinai· New York, NYWake Forest Baptist Medical Center· Winston-Salem, NCOhio State University· Columbus, OH

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