This trial is active, not recruiting.

Condition graft versus host disease
Treatments daclizumab, methylprednisolone
Phase phase 3
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

Study Design

Allocation randomized
Masking double-blind
Primary purpose supportive care

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).