Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fred Hutchinson Cancer Research Center
Treatments:
Beclomethasone
Methotrexate
Tacrolimus
Criteria
Inclusion

- Allogeneic HCT with marrow or growth-factor mobilized blood cells from an HLA-A, B, C,
DRB1, and HLA-DQB1-allele matched or single-allele or antigen mismatched related or
unrelated donor

- Use of myeloablative pre-transplant conditioning regimen with > 800 cGy total body
irradiation and cyclophosphamide, or high-dose busulfan and cyclophosphamide

- Use of methotrexate and tacrolimus for prevention of GVHD after allogeneic HCT

- Informed consent document signed

Exclusion

- Cord blood transplant recipients

- Use of T cell depletion or rabbit antithymocyte globulin to prevent acute GVHD

- Treatment with rabbit antithymocyte globulin or alemtuzumab within 3 months before the
date of HCT

- Participation in another therapeutic trial where the primary endpoint is related to
acute GVHD

- Hospitalization at the beginning of the pre-transplant conditioning regimen because of
pre-existing medical complications

- Glucocorticoid treatment at prednisone-equivalent doses > 0.2 mg/kg/day

- Known intolerance to BDP

- Anticipated inability to tolerate oral administration of study drug tablets for any
reason during the first two weeks after HCT

- Body weight < 35 kg (lower-dose formulations are not available for subjects with lower
body weight)

- Pregnancy or breast feeding

- Women of child-bearing potential who are unwilling to use a reliable method of
contraception

- Incarceration