MPD-RC 114
Research type
Research Study
Full title
Exploring the Potential of Dual Kinase JAK 1/2 Inhibitor Ruxolitinib (INC424) with Reduced Intensity Allogeneic Hematopoietic Cell Transplantation in Patients with Myelofibrosis
IRAS ID
133806
Contact name
Adam Mead
Contact email
Sponsor organisation
Consorzio Mario Negri Sud
Eudract number
2012-005010-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
116275, Investigational New Drug (IND)
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
MPD-RC 114 trial is an international, multicentre, not-for-profit, randomised, phase II trial promoted by the Myeloproliferative Disorders Research Consortium (MPD-RC). The study is being conducted at hospitals in the USA, Canada, Israel and Europe.
This study will investigate whether, in patients with myelofibrosis, adding the drug Ruxolitinib to the standard reduced intensity conditioning (RIC) regimen (chemotherapy to prepare the body for a bone marrow transplant) prior to bone marrow transplantation makes it more successful. Success in this trial is defined as the patient being alive, and without graft failure (when normal bone marrow function does not come back after a stem cell transplant) 100 days after the transplant.
Eligible patients will have myelofibrosis (MF), or myelofibrosis following polycythemia vera (PV), or following essential thrombocythemia (ET), and require a stem cell transplant.
Patients will be treated with Ruxolitinib tablets starting from 62 days prior to the start of the conditioning regimen. The drug will be given for 56 days, followed by 4 days of tapering, and will be stopped completely 48 hours prior to planned start of conditioning therapy. The patients will receive, as standard of care, reduce intensity conditioning regimen for 5 days followed by allogenic stem cell transplantation (bone marrow transplant). They will then be followed up for a maximum of 4 years.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1315
Date of REC Opinion
25 Nov 2014
REC opinion
Further Information Favourable Opinion