A Phase II Study to Evaluate the Efficacy of Oral Beclomethasone Dipropionate for Prevention of Acute GVHD After Hematopoietic Cell Transplantation With Myeloablative Conditioning Regimens
PRIMARY OBJECTIVES:
I. Assess the efficacy of oral BDP for prevention of acute GVHD after allogeneic
hematopoietic cell transplantation with myeloablative conditioning regimens.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral beclomethasone dipropionate 4 times daily beginning at the
start of the conditioning regimen and continuing through day 75 post-transplant. Patients
also receive a standard immunosuppressive regimen comprising tacrolimus and methotrexate
post-transplant.
ARM II: Patients receive oral placebo 4 times daily beginning at the start of the
conditioning regimen and continuing through day 75 post-transplant. Patients also receive a
standard immunosuppressive regimen comprising tacrolimus and methotrexate post-transplant.
In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed periodically.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Development of acute graft-versus-host disease (GVHD) with severity sufficient to require systemic immunosuppressive treatment
On or before day 90 after the transplant
No
Paul Martin
Principal Investigator
Fred Hutchinson Cancer Research Center
United States: Food and Drug Administration
2079.00
NCT00489203
April 2007
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |