Expired Study
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New York, New York 10029


Purpose:

RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.


Study summary:

OBJECTIVES: Primary - Determine the 4-week rate of complete response in patients with severe acute graft-vs-host disease (GVHD) treated with alemtuzumab, tacrolimus, and methylprednisolone within 100 days after undergoing allogeneic stem cell transplantation. Secondary - Determine the best response at 4 and 12 weeks in patients treated with this regimen. - Determine 6-month survival of patients treated with this regimen. - Determine the rate of infectious complications in patients treated with this regimen. - Determine rate of chronic GVHD in patients treated with this regimen. OUTLINE: This is an open-label, single-blind, multicenter study. Patients receive methylprednisolone IV on days 1-3 and then orally or IV on days 4-14; tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease; and alemtuzumab IV over 2 hours on days 4-6, 18, and 32. Treatment continues in the absence of unacceptable toxicity or the development of serious infection. After completion of study treatment, patients are followed at 2 and 4 weeks. PROJECTED ACCRUAL: A total of 9-34 patients will be accrued for this study within 8-12 months.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of acute graft-vs-host disease (GVHD) - Clinical grade C or D disease - No grade C disease with single organ skin involvement - Has undergone allogeneic stem cell transplantation within the past 100 days - Absolute neutrophil count > 500/mm^3 (donor-derived [> 60% by peripheral blood lymphocyte chimerism analyses]) - No development of GVHD after prior donor lymphocyte infusion - Must have received prior prophylactic cyclosporine or tacrolimus at the onset of acute GVHD PATIENT CHARACTERISTICS: Age - Over 18 Performance status - Not specified Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - No serologic evidence of active hepatitis B or C infection Renal - Creatinine ≤ 3.5 mg/dL - No requirement for dialysis Cardiovascular - No requirement for vasopressors Pulmonary - No requirement for a ventilator Other - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after completion of study treatment - No known HIV positivity - No active uncontrolled infection - No other organ dysfunction PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00109993


Primary Contact:

Principal Investigator
Mary Laughlin, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10029
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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