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