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
2 other identifiers
interventional
140
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedFebruary 3, 2021
March 1, 2015
3.6 years
June 20, 2007
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
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
- +11 more secondary outcomes
Study Arms (2)
Arm I
EXPERIMENTALPatients 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
ACTIVE COMPARATORPatients 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.
Interventions
Given orally
Given after transplant
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Martin
Fred Hutchinson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2007
First Posted
June 21, 2007
Study Start
April 1, 2007
Primary Completion
November 1, 2010
Last Updated
February 3, 2021
Record last verified: 2015-03