Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer
Condition: Graft Versus Host Disease; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases; Secondary Myelofibrosis
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Neoplasm Metastasis; Plasmacytoma; Myelodysplastic Syndromes; Primary Myelofibrosis; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Graft vs Host Disease; Syndrome
Intervention: anti-thymocyte globulin; busulfan; cyclophosphamide; mycophenolate mofetil; tacrolimus; polymerase chain reaction; polymorphism analysis; flow cytometry; laboratory biomarker analysis; pharmacogenomic studies; pharmacological study; allogeneic bone marrow transplantation; allogeneic hematopoietic stem cell transplantation; peripheral blood stem cell transplantation
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Busulfan; Tacrolimus; Antilymphocyte Serum; Immunosuppressive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: graft versus host disease; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); recurrent adult acute myeloid leukemia; untreated adult acute myeloid leukemia; untreated adult acute lymphoblastic leukemia; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia; stage III multiple myeloma; refractory multiple myeloma; de novo myelodysplastic syndromes; myelodysplastic/myeloproliferative disease, unclassifiable; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; secondary myelofibrosis; secondary acute myeloid leukemia; recurrent adult Burkitt lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult Hodgkin lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult T-cell leukemia/lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; recurrent adult acute lymphoblastic leukemia; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; adult nasal type extranodal NK/T-cell lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; stage III marginal zone lymphoma; stage IV marginal zone lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; adult acute lymphoblastic leukemia in remission; adult acute myeloid leukemia in remission; atypical chronic myeloid leukemia; noncontiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II mantle cell lymphoma; noncontiguous stage II marginal zone lymphoma; noncontiguous stage II small lymphocytic lymphoma; refractory hairy cell leukemia; stage I multiple myeloma; stage II multiple myeloma

Summary:

      RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell
      transplant helps stop the growth of cancer cells and helps stop the patient's immune system
      from rejecting the donor's stem cells. When certain stem cells from a donor are infused into
      the patient they may help the patient's bone marrow make stem cells, red blood cells, white
      blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune
      response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after
      the transplant may stop this from happening.

      PURPOSE: This phase II trial is studying how well giving busulfan together with
      cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in
      treating patients with hematologic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed diagnosis of 1 of the following:

               -  Acute myeloid leukemia

               -  Acute lymphocytic leukemia

               -  Chronic myelogenous leukemia beyond first chronic phase (i.e., 2nd chronic phase,
                  accelerated phase, or blast crisis)

               -  Multiple myeloma

               -  Myelodysplastic syndromes

               -  Malignant lymphoma

               -  Myelofibrosis

          -  Requirement for myeloablative conditioning regimen confirmed by attending physician

          -  Available donor must meet the following criteria:

               -  HLA phenotypically identical unrelated donor by low, intermediate, or high
                  resolution for HLA class I antigens, and by high resolution for HLA class II
                  antigens

               -  Matched at the A, B, and DRβ1 loci

               -  Single HLA-A or HLA-B antigen mismatch allowed

               -  Meets all National Marrow Donor Program or foreign registry criteria for
                  allogeneic bone marrow/stem cell donors

               -  Peripheral blood stem cells are the preferred product on this study but bone
                  marrow is allowed

          -  Karnofsky performance status 70-100%

          -  DLCO ≥ 50% predicted

          -  LVEF ≥ 45%

          -  Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 65 mL/min

          -  Serum total bilirubin ≤ 2.0 mg/dL

          -  Fertile patients must use effective contraception

        Exclusion Criteria:

          -  No active uncontrolled infection

          -  Not pregnant or nursing/negative pregnancy test

          -  No HIV infection

          -  No chronic active hepatitis B or C or evidence of cirrhosis on liver biopsy