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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