Status:
COMPLETED
Alemtuzumab and Glucocorticoids in Treating Newly Diagnosed Acute Graft-Versus-Host Disease in Patients Who Have Undergone a Donor Stem Cell Transplant
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Chronic Myeloproliferative Disorders
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
RATIONALE: Alemtuzumab and glucocorticoids, such as prednisone or methylprednisolone, may be an effective treatment for acute graft-versus-host disease caused by a donor stem cell transplant. PURPOSE...
Detailed Description
OBJECTIVES: * Determine whether the administration of low-dose alemtuzumab at the onset of acute graft-versus-host disease can accelerate withdrawal of glucocorticoids and decrease nonrelapsing morta...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00410657
Start Date
July 1 2006
Last Update
May 14 2010
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024