Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bone marrow that has been treated to remove certain white blood cells may reduce the chance of developing graft-versus-host disease following bone marrow transplantation.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of treated bone marrow with that of untreated bone marrow in preventing graft-versus-host disease in patients with acute or chronic leukemia who are undergoing bone marrow transplantation.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chimeric Therapies
• Treatments: Antilymphocyte Serum; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of one of the following:

• Acute myelogenous leukemia (AML) or acute lymphocytic leukemia (ALL) in first early relapse, second remission, or subsequent remission

• AML in first complete remission with one of the following adverse features:

• Antecedent hematologic disorder such as myelodysplasia

• AML resulting from prior chemotherapy or radiotherapy

• More than 1 course of induction chemotherapy to achieve remission or adverse cytogenetics such as Philadelphia chromosome 9:22, +8, +11; abnormal 12p; or deletions of chromosomes 5, 7, or 20 (3:3)

• ALL in first complete remission with poor risk cytogenetics such as

• Philadelphia chromosome 9:22, 8:14, or 4:11 OR

• WBC greater than 100,000/mm3 OR

• Time to achieve complete remission more than 4 weeks

• Chronic myelogenous leukemia in chronic or accelerated phase

• Myelodysplastic syndromes

• Refractory anemia with excess blasts (RAEB) OR

• RAEB in transformation

• Unrelated bone marrow donor available

• If matched at 6 of 6 HLA-A, -B, and -DR loci, patient must be 12 to 50 years

• If matched at 5 of 6 loci, patient must be 12 to 35 years

• No matched sibling donor available

• No uncontrolled CNS leukemia

PATIENT CHARACTERISTICS:

Age:

• See Disease Characteristics

• 12 to 50

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 12 weeks

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin less than 2.5 times upper limit of normal (ULN)

• SGOT or SGPT less than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• LVEF greater than 50% without medication

Pulmonary:

• DLCO and FVC at least 50% predicted

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other serious medical illness

• No uncontrolled diabetes mellitus

• No uncontrolled and/or active infection

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior immunotherapy and recovered

• At least 1 year since prior autologous transplantation

• No prior allogeneic transplantation

Chemotherapy:

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy (except hydroxyurea) and recovered

Endocrine therapy:

• At least 3 weeks since prior hormonal therapy and recovered

Radiotherapy:

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy and recovered

• No prior radiotherapy at doses that would preclude study

Surgery:

• Not specified