Clinical trial · Interventional
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
NCT00489203CI-TRIAL-00049816completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (136)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Adult Acute Lymphoblastic Leukemia in Remission | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia in Remission | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) | Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| beclomethasone dipropionate | Drug | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
| placebo | Drug | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- 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.
- interventionNames
- Drug: beclomethasone dipropionate
- Drug: tacrolimus
- Drug: methotrexate
- Procedure: allogeneic hematopoietic stem cell transplantation
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- 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.
- interventionNames
- Drug: placebo
- Drug: tacrolimus
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.