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

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.

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.

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