Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL

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

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus may prevent this from happening.

PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine plus total-body irradiation with that of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

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

Details

• Lead Sponsor: Simmons Cancer Center; University of Texas Southwestern Medical Center
• Treatments: Cyclophosphamide; Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate; Methotrexate; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of chronic lymphocytic leukemia or

• Diagnosis of non-Hodgkin's lymphoma

• Lymphoplasmacytic lymphoma

• Grade I follicular small cleaved cell lymphoma

• Grade II follicular mixed cell lymphoma

• Diffuse small cleaved cell lymphoma

• Small lymphocytic lymphoma

• Relapsed after at least 1 course of prior therapy

• Availability of a 6/6 human leukocyte antigen (HLA) A, B, and DR identical sibling donor

• Nonmyeloablative transplantation candidate

• No clinically significant effusions or ascites that would preclude administration of methotrexate

PATIENT CHARACTERISTICS:

-Age: 18 to 75

Performance status:

• Eastern Cooperative Oncology Group (ECOG) 0-2 OR Zubrod 0-2

• Life expectancy: At least 6 months

• Hematopoietic: Not specified

• Hepatic: Bilirubin no greater than 3 mg/dL

• Renal: Creatinine no greater than 2 mg/dL

• Cardiovascular: left ventricular ejection fraction (LVEF) at least 40% on multigated acquisition (MUGA) scan or echocardiogram

• Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO) at least 50% of predicted

OTHER:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled bacterial, viral, fungal, or parasitic infection

• Human Immunodeficiency Virus (HIV)1 and Human Immunodeficiency Virus (HIV)2 negative

• No other active malignancy except basal cell skin cancer

• No recent history of drug or alcohol abuse

• No other primary disease or comorbid illness that would severely limit life expectancy

PRIOR CONCURRENT THERAPY

• Biologic therapy:See Disease Characteristics

• Biologic therapy:Prior autologous bone marrow transplantation allowed if disease has progressed after transplantation

• Biologic therapy:No entry on study as part of a tandem autologous transplantation followed by nonmyeloablative allograft protocol

• Chemotherapy: Not specified

• Endocrine therapy: Not specified

• Radiotherapy:Not specified

• Surgery: Not specified