Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.

PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with relapsed hematologic malignancies or secondary myelodysplasia previously treated with high-dose 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: Antilymphocyte Serum; Busulfan; Fludarabine; Fludarabine phosphate; Lenograstim; Methotrexate; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed hematologic malignancies:

• Chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL)

• Absolute lymphocytosis of > 5,000/μL

• Lymphocytes must appear morphologically mature with < 55% prolymphocytes (CLL)

• Patients with > 55% prolymphocytes are considered as having PLL

• Lymphocyte phenotype with expression of CD20, CD19, and CD5 (CLL)

• Non-Hodgkin lymphoma

• Any WHO classification of histologic subtype

• Core biopsies acceptable for primary diagnosis and immunophenotyping

• Bone marrow biopsies as sole means of diagnosis not allowed for follicular lymphoma

• Hodgkin lymphoma

• Any WHO classification of histologic subtype

• Core biopsies acceptable for primary diagnosis and immunophenotyping

• Bone marrow biopsy is required

• Multiple myeloma

• Patients must have active disease requiring treatment (Durie-Salmon stage I-III)

• Acute myeloid leukemia

• Must have < 10% bone marrow blasts and no circulating blasts

• Myelodysplastic syndrome (MDS)

• MDS as define by WHO criteria

• Must have < 10% marrow blasts

• Relapsed or progressive disease or myelodysplasia ≥ 6 months after prior high-dose chemotherapy with autologous hematopoietic cell support

• Prior syngeneic transplantation allowed

• Healthy donor meeting one of the following criteria:

• HLA-identical sibling (6/6)

• Serologic typing for class I (A, B) and molecular typing for class II (DRB1) required

• 8/8 matched-unrelated donor

• Molecular identity at HLA A, B, C, and DRB1 by high-resolution typing required

• No syngeneic donors

PATIENT CHARACTERISTICS:

• Creatinine clearance ≥ 40 mL/min

• Total bilirubin ≤ 2 mg/dL

• AST ≤ 3 times upper limit of normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• DLCO ≥ 40% with no symptomatic pulmonary disease

• LVEF ≥ 30% by MUGA or ECHO

• No uncontrolled diabetes mellitus or active serious infection

• No known hypersensitivity to E.coli-derived products

• No HIV infection

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 weeks should elapse between prior standard cytotoxic chemotherapy, radiation therapy, or surgery and the planned start of the preparative regimen on day -7