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Phase III Randomized Study of FK506 vs CYSP as GVHD Prophylaxis Following Allogeneic Bone Marrow Transplantation (Summary Last Modified 05/94)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Supportive care

Closed

12 and over

WSU-Z-1093-93
NCI-V94-0363

Objectives

I.  Assess the efficacy and safety of FK506 vs. cyclosporine (both 
administered with a standard short course of methotrexate) in the prevention 
of graft-versus-host disease after an allogeneic bone marrow transplant from a 
genotypically HLA-identical sibling donor.

Entry Criteria

Disease Characteristics:


Malignancy for which an allogeneic bone marrow transplant (BMT)
from a sibling donor is planned

  Patient-donor HLA-identical genotype required

  No T-cell depleted BMT

Prior/Concurrent Therapy:


No prior transplants

Patient Characteristics:


Age:
  12 and older

Performance status:
  Not specified

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Creatinine less than 3.0 mg/dl

Other:
  No known hypersensitivity to Cremophor or related products
  No known carrier of HIV viruses
  No pregnant or nursing women
     Negative pregnancy test required unless surgically sterile
  Effective birth control required of fertile patients
     receiving FK506

Expected Enrollment

300 evaluable patients will be studied at 10-20 centers.

Outline

Randomized study.  Patients are randomized prior to allogeneic bone marrow 
transplantation (BMT).

Arm I:  GVHD Prophylaxis.  FK506; with Methotrexate, MTX, NSC-740.

Arm II:  GVHD Prophylaxis.  Cyclosporine, CYSP, NSC-290193; with MTX.

Trial Contact Information

Trial Lead Organizations

Barbara Ann Karmanos Cancer Institute

Voravit Ratanatharathorn, MD, Protocol chair(Contact information may not be current)
Ph: 734-936-1831; 800-865-1125

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.