Eligibility Module

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Eligibility Module

The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.

Eligibility Module path is as follows:

Study -> Protocol Section -> Eligibility Module

Eligibility Module

Ignite Creation Date: 2025-12-24 @ 7:48 PM
Ignite Modification Date: 2025-12-24 @ 7:48 PM
NCT ID: NCT00489203
Eligibility Criteria: 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
Healthy Volunteers: False
Sex: ALL
Study: NCT00489203
Study Brief:
Protocol Section: NCT00489203