S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: fludarabine phosphate; melphalan; methotrexate; tacrolimus; allogeneic bone marrow transplantation; peripheral blood stem cell transplantation
Intervention description: 30 mg/m^2 on days -6 to -2 (2-6 days before transplant).; 70 mg/m^2 on days -3 and -2 (2-3 days before transplant).; 5 mg/m^2 on days 1, 3, and 7 post-transplant.; 0.03 mg/kg bid on days -3 to 100 post-transplant.; if donor bone marrow stem cells are harvested; if donor peripheral blood stem cells are harvested
Intervention MeSH terms: Methotrexate; Fludarabine phosphate; Fludarabine; Melphalan; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent adult Hodgkin lymphoma; recurrent small lymphocytic lymphoma; recurrent mantle cell lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse large cell lymphoma

Summary:

      RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, 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). Sometimes the transplanted cells from a donor can
      also make an immune response against the body's normal cells. Giving tacrolimus and
      methotrexate after transplant may stop this from happening.

      PURPOSE: This phase II trial is studying how well giving fludarabine together with melphalan
      followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor
      stem cell transplant for relapsed lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of lymphoma of 1 of the following types:

               -  Diffuse large B-cell lymphoma

               -  Follicular lymphoma

                    -  Grades 1, 2, or 3

               -  Primary mediastinal lymphoma

               -  Mantle cell lymphoma

               -  Small lymphocytic lymphoma

               -  Hodgkin's lymphoma

               -  Transformed lymphoma

          -  Relapsed after prior autologous bone marrow transplantation (BMT)

               -  More than 180 days post BMT

          -  Received ≥ 1 course of chemotherapy after BMT relapse

               -  Achieved a complete response OR a partial response to chemotherapy

                    -  Largest residual tumor dimension ≤ 2 cm

          -  No clinical or laboratory evidence of CNS involvement by lymphoma

          -  HLA-identical donor available, meeting 1 of the following criteria:

               -  Sibling donor with 5/6 or 6/6 alleles matching by genotyping

                    -  No monozygotic identical twins

               -  Unrelated donor with 10/10 alleles matching by genotyping

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Cardiovascular

          -  LVEF ≥ 40% by MUGA or 2-D echocardiogram (2-D ECHO)

          -  No significant cardiac abnormalities by MUGA or 2-D ECHO

          -  No uncompensated coronary artery disease by ECG or physical exam

          -  None of the following within the past 6 months:

               -  Myocardial infarction

               -  Unstable angina

               -  Uncontrolled atrial fibrillation

          -  None of the following within the past 3 months:

               -  Severe peripheral vascular disease

               -  Venous stasis ulcers

               -  Deep venous or arterial thrombosis

          -  No uncontrolled hypertension

        Pulmonary

          -  DLCO (corrected) and total lung capacity ≥ 40% of predicted

          -  No requirement for continuous supplemental oxygen

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  No AIDS

          -  No active bacterial, viral, or fungal infection

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

          -  No history of uncontrolled seizures

          -  No diabetic ulcers within the past 3 months

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  See Disease Characteristics

          -  No more than 1 prior bone marrow transplantation

        Chemotherapy

          -  See Disease Characteristics

          -  More than 21 days since prior chemotherapy and recovered

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  More than 4 weeks since prior radiotherapy

        Surgery

          -  More than 4 weeks since prior major surgery except placement of a venous access device