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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT00410657
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Newly diagnosed acute graft-versus-host disease (GVHD)
* Grade IIB-IV disease
* Requires glucocorticoids for treatment of GVHD, as indicated by 1 of the following:
* Initial treatment with prednisone or methylprednisolone at 2 mg/kg is indicated (in the judgement of the attending physician) by any of the following:
* Severity of GVHD requires hospitalization
* GVHD manifestations include symptoms other than anorexia, nausea, and vomiting
* GVHD begins within 2-3 weeks after hematopoietic stem cell transplantation (HSCT)
* GVHD manifestations progress rapidly from 1 day to the next before treatment
* Initial treatment with prednisone or methylprednisolone at 1 mg/kg did not produce adequate clinical improvement within the first 4 days (in the judgement of the attending physician)
* Has undergone allogeneic HSCT with myeloablative conditioning
* No nonmyeloablative conditioning or autologous HSCT
* No primary treatment of acute GVHD with methylprednisolone at any of the following doses:
* More than 2 mg/kg/day at any time
* 2 mg/kg/day for \> 72 hours
* 1 mg/kg/day for \> 96 hours
* No presence of distinctive or diagnostic manifestations of chronic GVHD
* No relapsed, refractory, or secondary malignancy
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 20-100% OR Lanksy PS 20-100%
* Life expectancy ≥ 1 month
* Absolute neutrophil count ≥ 500/mm\^3
* Negative pregnancy test
* No Mini Mental State Exam score \< 24/30 or confusion (for patients \> 12 years of age)
* No history of type I hypersensitivity reaction to alemtuzumab or any of its components
* No increasing levels of viremia by serial quantitative viral plasma polymerase chain reaction assays
* No invasive viral or fungal disease that does not respond to appropriate antiviral or antifungal medications
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No systemic immunosuppression tapered or stopped for treatment of leukemic relapse or minimal residual disease
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00410657
Study Brief:
Protocol Section:
NCT00410657