Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing … (NCT00489203) | Clinical Trial Compass
CompletedPhase 2
Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
United States140 participantsStarted 2007-04
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Development of acute graft-versus-host disease (GVHD) with severity sufficient to require systemic immunosuppressive treatment
Timeframe: On or before day 90 after the transplant