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Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Graft Versus Host Disease

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Trial Information

Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Stephanie J. Lee, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000269672

NCT ID:

NCT00053976

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Graft Versus Host Disease
  • graft versus host disease
  • Graft vs Host Disease

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Brigham and Women's HospitalBoston, Massachusetts  02115
Baylor University Medical CenterDallas, Texas  75246