Chronic Myelomonocytic Leukemia Clinical Trial
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
| NCT number | NCT00489203 |
| Other study ID # | 2079.00 |
| Secondary ID | NCI-2009-01544 |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | April 2007 |
| Verified date | March 2015 |
| Source | Fred Hutchinson Cancer Research Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 140 |
| Est. completion date | |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Fred Hutchinson Cancer Research Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Cumulative glucocorticoid dose (measured as prednisone equivalents) per kg body weight | First 75 days after HCT | ||
| Secondary | Peak and average skin, liver and gut morbidity stages and overall grades | To day 90 after HCT | ||
| Secondary | Modified average acute GVHD index score | To day 90 after HCT | ||
| Secondary | Cumulative incidence of systemic immunosuppressive treatment for acute GVHD | At any time after HCT | ||
| Secondary | 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 | ||
| Secondary | Cumulative incidence of biopsy-proven gastrointestinal GVHD | On or before day 90 after the transplant | ||
| Secondary | Proportion of patients with grade IIa GVHD | On or before day 90 after the transplant | ||
| Secondary | Proportions of patients with grades IIa and IIb - IV GVHD | On or before day 90 after the transplant | ||
| Secondary | Cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment | At any time after HCT | ||
| Secondary | Number of days in the hospital | During the first 90 days after HCT | ||
| Secondary | Non-relapse mortality | At any time after HCT | ||
| Secondary | Overall survival | At any time after HCT | ||
| Secondary | Survival | At 200 days after HCT | ||
| Secondary | Safety | On or before day 90 after the transplant | ||
| Secondary | Feasibility | First 75 days after HCT | ||
| Secondary | Survival without recurrent malignancy | At any time after HCT |
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