MedTrace Logo

Ruxolitinib Prior to Transplant in Patients With Myelofibrosis

NCT01790295 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-03-20

Study results available
· View outcomes & findings →

Summary

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.

Conditions

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

Interventions

DRUG

Ruxolitinib Pre- Hematopoietic cell transplantation (HCT)

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.

Sponsors & Collaborators

  • Myeloproliferative Disorders-Research Consortium

    collaborator NETWORK

  • National Cancer Institute (NCI)

    collaborator NIH

  • Incyte Corporation

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • John Mascarenhas

    lead OTHER

Principal Investigators

  • John Mascarenhas, MD · Icahn School of Medicine at Mount Sinai

  • Vikas Gupta, MD, FRCP, FRCPath · University of Toronto

  • Adam Mead, MD · University of Oxford, John Radcliffe Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-10-26
Completion
2017-10-26

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01790295 on ClinicalTrials.gov