Ruxolitinib Prior to Transplant in Patients With Myelofibrosis

PHASE2TerminatedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

October 26, 2017

Study Completion Date

October 26, 2017

Conditions
Primary MyelofibrosisPost Polycythemia Vera MyelofibrosisPost 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.

Trial Locations (8)

10029

Icahn School of Medicine at Mount Sinai, New York

27103

Wake Forest Baptist Medical Center, Winston-Salem

30322

Emory Hospital, Atlanta

43210

Ohio State University, Columbus

60611

Northwestern University, Robert h. Lurie Comprehensive Cancer Center, Chicago

66205

University of Kansas Cancer Center, Westwood

M5G 2M9

Princess Margaret Cancer Centre, University of Toronto, Toronto

OX3 9DS

University of Oxford, Oxford

Sponsors
All Listed Sponsors
collaborator

Myeloproliferative Disorders-Research Consortium

NETWORK

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Incyte Corporation

INDUSTRY

collaborator

Novartis

INDUSTRY

lead

John Mascarenhas

OTHER

NCT01790295 - Ruxolitinib Prior to Transplant in Patients With Myelofibrosis | Biotech Hunter | Biotech Hunter