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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.


Sponsor: Fred Hutchinson Cancer Research Center

Current Primary Outcome: Development of acute graft-versus-host disease (GVHD) with severity sufficient to require systemic immunosuppressive treatment [ Time Frame: On or before day 90 after the transplant ]

Original Primary Outcome: Development of acute graft-vs-host disease (GVHD) with severity sufficient to require systemic immunosuppressive treatment on or before day 90 post-transplant

Current Secondary Outcome:

  • Cumulative glucocorticoid dose (measured as prednisone equivalents) per kg body weight [ Time Frame: First 75 days after HCT ]
  • Peak and average skin, liver and gut morbidity stages and overall grades [ Time Frame: To day 90 after HCT ]
  • Modified average acute GVHD index score [ Time Frame: To day 90 after HCT ]
  • Cumulative incidence of systemic immunosuppressive treatment for acute GVHD [ Time Frame: At any time after HCT ]
  • Cumulative incidence of topical therapy for acute GVHD, including psoralen and UV irradiation, hydrocortisone cream, topical tacrolimus, oral BDP, or oral swish and spit dexamethasone [ Time Frame: On or before day 90 after the transplant ]
  • Cumulative incidence of biopsy-proven gastrointestinal GVHD [ Time Frame: On or before day 90 after the transplant ]
  • Proportion of patients with grade IIa GVHD [ Time Frame: On or before day 90 after the transplant ]
  • Proportions of patients with grades IIa and IIb - IV GVHD [ Time Frame: On or before day 90 after the transplant ]
  • Cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment [ Time Frame: At any time after HCT ]
  • Number of days in the hospital [ Time Frame: During the first 90 days after HCT ]
  • Non-relapse mortality [ Time Frame: At any time after HCT ]
  • Overall survival [ Time Frame: At any time after HCT ]
  • Survival [ Time Frame: At 200 days after HCT ]
  • Safety [ Time Frame: On or before day 90 after the transplant ]
  • Feasibility [ Time Frame: First 75 days after HCT ]
  • Survival without recurrent malignancy [ Time Frame: At any time after HCT ]


Original Secondary Outcome:

  • Safety
  • Feasibility
  • Cumulative glucocorticoid dose per kg body weight during the first 75 days post-transplant
  • Peak and average skin, liver, and gut morbidity stages and overall grades during the first 90 days post-transplant
  • Modified average acute GVHD index score during the first 90 days post-transplant
  • Cumulative incidence of systemic immunosuppressive treatment for acute GVHD at any time post-transplant
  • Cumulative incidence of topical therapy for acute GVHD, including psoralen and UV irradiation, hydrocortisone cream, topical tacrolimus, oral BDP, or oral swish and spit dexamethasone
  • Cumulative incidence of biopsy-proven gastrointestinal GVHD
  • Proportion of patients with grade IIa and/or IIb-IV GVHD
  • Cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment
  • Number of days in the hospital during the first 90 days post-transplant
  • Non-relapse mortality
  • Overall survival
  • Survival at 200 days post-transplant
  • Survival without recurrent malignancy


Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: June 20, 2007
Date Started: April 2007
Date Completion:
Last Updated: March 5, 2015
Last Verified: March 2015