Clinical Trials Directory

Trials / Completed

CompletedNCT00489203

Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
140 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

RATIONALE: Beclomethasone dipropionate may be effective in preventing acute graft-versus-host disease in patients undergoing a stem cell transplant for hematologic cancer. PURPOSE: This randomized phase II trial is studying how well beclomethasone dipropionate works in preventing acute graft-versus-host disease in patients undergoing a donor stem cell transplant for hematologic cancer.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGbeclomethasone dipropionateGiven orally
DRUGplaceboGiven orally
DRUGtacrolimusGiven after transplant
DRUGmethotrexateGiven after transplant
PROCEDUREallogeneic hematopoietic stem cell transplantationUndergo stem cell transplant

Timeline

Start date
2007-04-01
Primary completion
2010-11-01
First posted
2007-06-21
Last updated
2021-02-03

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00489203. Inclusion in this directory is not an endorsement.