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

Sponsors

Lead Sponsor: Fred Hutchinson Cancer Research Center

Source Fred Hutchinson Cancer Research Center
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 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.

Overall Status Completed
Start Date 2007-04-01
Primary Completion Date 2010-11-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Development of acute graft-versus-host disease (GVHD) with severity sufficient to require systemic immunosuppressive treatment On or before day 90 after the transplant
Secondary Outcome
Measure Time Frame
Cumulative glucocorticoid dose (measured as prednisone equivalents) per kg body weight First 75 days after HCT
Peak and average skin, liver and gut morbidity stages and overall grades To day 90 after HCT
Modified average acute GVHD index score To day 90 after HCT
Cumulative incidence of systemic immunosuppressive treatment for acute GVHD 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 On or before day 90 after the transplant
Cumulative incidence of biopsy-proven gastrointestinal GVHD On or before day 90 after the transplant
Proportion of patients with grade IIa GVHD On or before day 90 after the transplant
Proportions of patients with grades IIa and IIb - IV GVHD On or before day 90 after the transplant
Cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment At any time after HCT
Number of days in the hospital During the first 90 days after HCT
Non-relapse mortality At any time after HCT
Overall survival At any time after HCT
Survival At 200 days after HCT
Safety On or before day 90 after the transplant
Feasibility First 75 days after HCT
Survival without recurrent malignancy At any time after HCT
Enrollment 140
Condition
Intervention

Intervention Type: Drug

Intervention Name: beclomethasone dipropionate

Description: Given orally

Arm Group Label: Arm I

Intervention Type: Drug

Intervention Name: placebo

Description: Given orally

Arm Group Label: Arm II

Other Name: PLCB

Intervention Type: Drug

Intervention Name: tacrolimus

Description: Given after transplant

Intervention Type: Drug

Intervention Name: methotrexate

Description: Given after transplant

Intervention Type: Procedure

Intervention Name: allogeneic hematopoietic stem cell transplantation

Description: Undergo stem cell transplant

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

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Paul Martin Principal Investigator Fred Hutchinson Cancer Research Center
Location
Facility:
Hackensack University Medical Center | Hackensack, New Jersey, 07601, United States
Fred Hutchinson Cancer Research Center | Seattle, Washington, 98109, United States
Location Countries

United States

Verification Date

2015-03-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm I

Type: Experimental

Description: 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.

Label: Arm II

Type: Active Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News