Exploring the Potential of Dual Kinase JAK 1/2 Inhibitor Ruxolitinib (INC424) With Reduced Intensity Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of 100-day survival without graft failure
To determine the feasibility of combining Ruxolitinib (INC424) with a RIC regimen likely to produce success post transplantation, success being defined as patient being alive, and without graft failure at day 100-post allogeneic stem cell transplantation (in patients who receive (a) related donor transplant and in those who receive (b) an unrelated donor transplant.
Day 100-post allogeneic stem cell transplantation
No
John Mascarenhas, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
United States: Food and Drug Administration
GCO 12-1809
NCT01790295
February 2013
February 2021
Name | Location |
---|---|
University of Illinois at Chicago | Chicago, Illinois 60612 |
University of Utah | Salt Lake City, Utah |
Ohio State University | Columbus, Ohio 43210 |
Mayo Clinic - Arizona | Scottsdale, Arizona 85259 |
Emory Hospital | Atlanta, Georgia 30322 |
Icahn School of Medicine at Mount Sinai | New York, New York 10029 |
Weill CornellMedical College | New York, New York 10065 |