Fludarabine, Busulfan, and Antilymphocyte Globulin Followed by Donor Stem Cell Transplant in Treating Older Patients With Hematological Cancer

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

Summary

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antilymphocyte globulin before transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well fludarabine, busulfan, and antilymphocyte globulin together with donor stem cell transplant works in treating older patients with hematological cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Paoli-Calmettes
• Treatments: Antibodies; Antilymphocyte Serum; Busulfan; Fludarabine; Fludarabine phosphate; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of a hematological malignancy

• Candidate for an allogeneic hematopoietic stem cell transplantation

• Available HLA-identical related donor

PATIENT CHARACTERISTICS:

• WHO performance status (PS) 0-1 OR Karnofsky PS 70-100%

• Life expectancy > 6 months

• LVEF ≥ 40%

• DLCO ≥ 50%

• Creatinine clearance ≥ 30 mL/min

• Transaminases and/or bilirubin ≤ 2 times upper limit of normal (ULN)

• No other cancer within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix

• No human T-cell leukemia virus type 1 positivity

• No HIV positivity

• No uncontrolled bacterial, viral, or fungal infection

• No contraindications to the study drugs

• No concurrent serious and uncontrolled disease

PRIOR CONCURRENT THERAPY:

• At least 1 month since prior participation in a clinical trial