Antithymocyte Globulin and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Chemotherapy With or Without Radiation Therapy Followed By Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine after transplant may stop this from happening.

PURPOSE: This randomized clinical trial is studying how well giving antithymocyte globulin together with cyclosporine works in preventing graft-versus-host disease in patients who are undergoing chemotherapy with or without radiation therapy followed by donor stem cell transplant for acute lymphoblastic leukemia or acute myeloid leukemia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antilymphocyte Serum; Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins

Criteria

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia

• In first complete remission or second complete remission

• Secondary AML allowed

• HLA-A, -B, and -DRB1 identical related donor available AND must be fully matched at Class II by high-resolution molecular HLA typing (at least 4 digits)

• Currently receiving a myeloablative conditioning regimen that includes cyclophosphamide

• All patients from a center should receive the same conditioning regimen throughout the study

• No fludarabine or other purine analogues (e.g. cladribine or pentostatin) as part of conditioning regimen

• No uncontrolled CNS disease

PATIENT CHARACTERISTICS:

Age

• 18 to 55

Performance status

• ECOG 0-3

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin < 2 mg/dL

• ALT and/or AST ≤ 3 times normal

Renal

• Creatinine < 2.0 mg/dL OR

• Creatinine clearance > 50 mL/min

Cardiovascular

• Ejection fraction > 40%

• No severe cardiac disease

Other

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known contraindication to administration of rabbit anti-thymocyte globulin

• No current drug or alcohol abuse

• No significant medical or psychosocial problem or unstable disease state (including, but not limited to, morbid obesity) that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior or concurrent bone marrow transplantation from a donor who has positive serology for HIV, hepatitis B virus, hepatitis C virus, or syphilis

• No IV immunoglobulin prior to engraftment

• No concurrent ex vivo engineered or processed graft (CD34+ enrichment or T-cell depletion)

Chemotherapy

• See Disease Characteristics

• No prior or concurrent methotrexate for graft-vs-host disease prophylaxis

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 30 days since prior experimental agents

• No other concurrent investigational agents

• Enrollment in investigational studies (i.e., anti-microbial agents) allowed only for life threatening events or after exhausting other treatment modalities