Non Hodgkin Lymphoma Clinical Trial
Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
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.
Full 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.
Eligibility 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
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There are 2 Locations for this study
Hackensack New Jersey, 07601, United States
Seattle Washington, 98109, United States
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