Cyclophosphamide and/or Mycophenolate Mofetil With or Without Tacrolimus in Treating Patients Who Are Undergoing a Donor Bone Marrow or Peripheral Stem Cell Transplant for Hematologic Cancer

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

Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor bone marrow or 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). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after transplant may stop this from happening.

PURPOSE: This phase I trial is studying cyclophosphamide and/or mycophenolate mofetil with or without tacrolimus to see which is the best regimen in treating patients who are undergoing a donor bone marrow or stem cell transplant for hematologic cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following hematologic malignancies:

• Stage II or III multiple myeloma

• Amyloidosis

• Myelofibrosis with ≥ 2 of the following high-risk features:

• Over 55 years of age

• Hemoglobin < 10 g/dL

• WBC < 3,000/mm^3 OR > 10,000/mm^3

• Platelet count < 100,000/mm^3

• Cytogenetic abnormalities

• Mycosis fungoides, meeting 1 of the following criteria:

• Stage IIB or III disease with evidence of histologic conversion to an aggressive lymphoma

• Must demonstrate chemosensitivity

• Stage IV disease

• Paroxysmal nocturnal hemoglobinuria

• Not meeting criteria for other bone marrow transplantation (BMT) or treatment studies

• Diagnosis of 1 of the following hematologic malignancies, for which patient is not eligible for potentially curative allogeneic BMT due to end-organ dysfunction, age 65 to 75, or the amount of prior chemotherapy:

• Acute myeloid or acute lymphoblastic leukemia

• High-risk disease in first or second (or further) complete remission

• Relapsed aggressive non-Hodgkin's lymphoma

• Not eligible for autologous or standard allogeneic BMT

• Hodgkin's lymphoma in second or further complete or partial remission

• Not eligible for autologous or standard allogeneic BMT

• Myelodysplastic syndromes or myelodysplastic/myeloproliferative diseases

• Any of the following subtypes:

• Refractory anemia with excess blasts (RAEB)

• RAEB in transformation

• Chronic myelomonocytic leukemia

• Any morphologic subtype with multiple chromosomal abnormalities

• Any subset with life-threatening cytopenias in all 3 cell lines, defined as platelet count ≤ 20,000/mm^3, absolute neutrophil count ≤ 500/mm^3, and reticulocyte count ≤ 50,000/mm^3

• Meets both of the following criteria:

• Less than 20% blasts by bone marrow biopsy

• Not eligible for standard allogeneic BMT

• No refractory anemia with ringed sideroblasts

• No 5q syndrome

• Stage III or IV chronic lymphocytic leukemia

• Not meeting criteria for other BMT studies

• Chronic myelogenous leukemia in first or second chronic phase

• Not meeting criteria for other BMT studies or treatment

• Stage III or IV indolent small lymphocytic or follicular lymphoma

• Not eligible for autologous or standard allogeneic BMT or other active protocols at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

• Must have an HLA-identical related donor available

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin ≤ 3.0 mg/dL

• AST ≤ 175 U/L

• ALT ≤ 200 U/L

Renal

• Creatinine ≤ 3.0 mg/dL

Cardiovascular

• LVEF ≥ 30%

Pulmonary

• FEV_1 ≥ 40% predicted

• Forced vital capacity ≥ 40% predicted

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

PRIOR CONCURRENT THERAPY:

Chemotherapy

• See Disease Characteristics