Clinical Trials Logo
NCT number NCT01790295
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact
Status Recruiting
Phase Phase 2
Start date February 2013
Completion date February 2021

Clinical Trial 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.


Clinical Trial Description

A two- stage Simon Phase II study will be conducted in each of two groups of patients: related and unrelated donor transplants. In each donor transplant group, the first stage of this design will include 11 patients evaluated for death or graft failure by 100 days post-transplant. In each stratum, we will enroll additional patients (up to 20%) of stratum total to take into account exclusions due to donor failure (such as donor deemed unsuitable for stem cell donation due to medical or other reasons) only. Those patients who have toxicities related to Ruxolitinib and not been able to reach HCT due to these toxicities will be included in the estimation of overall failure rates. Only those patients who are excluded based on donor related issues without any regimen related complications will be excluded from the estimation of failure rates. However, all data on these patients will be reported.


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


See also
Status Clinical Trial Phase
 Recruiting NCT02871323 - Durvalumab in Treating Patients With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis Phase 1
 Terminated NCT02091752 - A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial) Phase 2
 Completed NCT01445769 - Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis Phase 2
 Active, not recruiting NCT01178281 - Phase-3 Double-Blind, Placebo-Controlled Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence Myelofibrosis and RBC-Transfusion-Dependence Phase 3
 Completed NCT01233921 - Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer N/A
 Active, not recruiting NCT01298934 - LBH589 (Panobinostat) for the Treatment of Myelofibrosis Phase 1/Phase 2
 Terminated NCT00387426 - Sunitinib in Treating Patients With Idiopathic Myelofibrosis Phase 2
 Active, not recruiting NCT00095784 - Decitabine in Treating Patients With Myelofibrosis Phase 2
 Recruiting NCT02917096 - Ruxolitinib Phosphate and Chemotherapy Given Before and After Reduced Intensity Donor Stem Cell Transplant in Treating Patients With Myelofibrosis N/A
 Recruiting NCT02530619 - Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia N/A
 Recruiting NCT02251821 - JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis Phase 2
 Recruiting NCT01981850 - A Phase 2 Study Of PRM-151 In Subjects With Myelofibrosis Phase 2
 Active, not recruiting NCT01731951 - Imetelstat Sodium in Treating Patients With Primary or Secondary Myelofibrosis Phase 2
 Completed NCT01371617 - A Phase 2 Study With IPI-926 in Patients With Myelofibrosis Phase 2
 Withdrawn NCT02528877 - Ruxolitinib Phosphate, Tacrolimus and Sirolimus in Preventing Acute Graft-versus-Host Disease During Reduced Intensity Donor Hematopoietic Cell Transplant in Patients With Myelofibrosis Phase 1
 Withdrawn NCT02584777 - A Phase II Non-Controlled, Open-Label, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Pacritinib in Myelofibrosis Phase 2
 Completed NCT01236638 - Extension Study Evaluating the Long Term Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET) Phase 2
 Completed NCT00935987 - Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET) Phase 1/Phase 2
 Completed NCT00112593 - Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer N/A
 Recruiting NCT02129101 - Azacitidine and Sonidegib or Decitabine in Treating Patients With Myeloid Malignancies Phase 1