Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant 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 system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with chemotherapy and autologous stem cell transplant.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Allopurinol; Antilymphocyte Serum; Busulfan; Fludarabine; Fludarabine phosphate; Methotrexate; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed hematologic malignancy, including one of the following:

• Chronic lymphocytic leukemia (CLL)

• Absolute lymphocytosis greater than 5,000/mm^3

• Lymphocytes must appear morphologically mature with less than 55% prolymphocytes

• Lymphocyte phenotype with expression of CD19 and CD5

• Prolymphocytic leukemia (PLL)

• Morphologically confirmed

• Absolute lymphocytosis greater than 5,000/mm^3

• More than 55% prolymphocytes

• Non-Hodgkin's lymphoma or Hodgkin's lymphoma

• Any WHO histologic subtype allowed except mantle cell lymphoma

• Core biopsies allowed if they contain adequate tissue for primary diagnosis and immunophenotyping

• No bone marrow biopsy as the sole diagnostic means for follicular lymphoma

• Multiple myeloma

• Active disease requiring treatment

• Durie-Salmon stage I, II, or III

• Acute myeloid leukemia

• Documented control (i.e., less than 10% bone marrow blasts and no circulating blasts)

• Myelodysplastic syndromes

• Documented disease by WHO criteria

• Must have evidence of relapse/progression at least 6 months after prior high-dose chemotherapy with autologous hematopoietic stem cell support

• Absence of CD23 expression for CLL or PLL allowed provided there is no morphologic evidence of mantle cell lymphoma

• Availability of any of the following donor types:

• HLA-identical sibling (6/6)

• 9/10 matched related donor by high-resolution molecular typing at HLA A, B, C, DRB1, and DQB1 loci

• Only a single mismatch at one class I or II allele allowed

• 10/10 matched unrelated donor by high-resolution molecular typing at HLA A, B, C, DRB1, and DQB1 loci

• No syngeneic donors

PATIENT CHARACTERISTICS:

Age

• Under 70

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin no greater than 3 times upper limit of normal (ULN)

• AST no greater than 3 times ULN

Renal

• Creatinine clearance at least 40 mL/min

Cardiovascular

• LVEF at least 30% by MUGA

Pulmonary

• DLCO greater than 40%

• No symptomatic pulmonary disease

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No uncontrolled diabetes mellitus

• No active serious infection

• No known hypersensitivity to E. coli-derived products

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

• More than 4 weeks since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• More than 4 weeks since prior surgery