Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease
This trial is active, not recruiting.
|Condition||graft versus host disease|
|Sponsor||Dana-Farber Cancer Institute|
|Collaborator||National Cancer Institute (NCI)|
|Start date||October 2002|
|Trial identifier||NCT00053976, CDR0000269672, DFCI-99279, ROCHE-RPCI-DS-0218, RPCI-DS-0218|
RATIONALE: Daclizumab combined with methylprednisolone may be an effective treatment for acute graft-versus-host disease caused by bone marrow transplantation. It is not yet known if methylprednisolone is more effective with or without daclizumab in treating acute graft-versus-host disease.
PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without daclizumab in treating patients who have acute graft-versus-host disease following donor bone marrow transplantation.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Boston, MA||Brigham and Women's Hospital||no longer recruiting|
|Boston, MA||Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||no longer recruiting|
|Boston, MA||Massachusetts General Hospital Cancer Center||no longer recruiting|
|Minneapolis, MN||University of Minnesota Cancer Center||no longer recruiting|
|Buffalo, NY||Roswell Park Cancer Institute||no longer recruiting|
|New York, NY||Memorial Sloan-Kettering Cancer Center||no longer recruiting|
|Portland, OR||Cancer Institute at Oregon Health and Science University||no longer recruiting|
|Dallas, TX||Baylor University Medical Center||no longer recruiting|
|Primary purpose||supportive care|
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Acute graft-versus-host disease (GVHD) requiring systemic therapy - Grade 2 (skin GVHD) - Grade 2-4 (overall GVHD) - Received allogeneic bone marrow transplantation - No acute GVHD diagnosed solely by upper gastrointestinal involvement - No GVHD from donor lymphocyte infusion PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No mental or emotional conditions that would preclude study therapy - No known hypersensitivity to daclizumab PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior daclizumab Chemotherapy - Not specified Endocrine therapy - More than 7 days since prior prophylactic or therapeutic steroids at greater than 1 mg/kg/day - Steroids for amphotericin premedication allowed provided dose is less than 1 mg/kg/day Radiotherapy - Not specified Surgery - Not specified Other - More than 30 days since prior investigational therapies
|Official title||Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo|
|Description||OBJECTIVES: - Compare response to treatment in patients with acute graft-versus-host disease (GVHD) treated with methylprednisolone with or without daclizumab. - Compare differences in total methylprednisolone dose and complications in patients treated with these regimens. - Compare mortality, days of antibiotics and antifungal therapy, and required hospital days within the first 100 days for patients treated with these regimens. - Compare overall survival and incidence of chronic GVHD at 1 year in patients treated with these regimens. OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to prior graft-versus-host disease (GVHD) prophylaxis (immunosuppressive therapy vs T-cell depletion), GVHD organ manifestation (skin only vs other), donor type (6/6 matched sibling vs other), and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive methylprednisolone or equivalent corticosteroid IV or orally and daclizumab IV over 15 minutes on days 0, 3, 7, 14, and then weekly as indicated until day 100. - Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo. Patients are followed at 1 year and then annually thereafter. PROJECTED ACCRUAL: A total of 166-190 patients will be accrued for this study within 2 years.|
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