Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
Condition: Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Plasmacytoma; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bone marrow
      transplantation may be able to replace immune cells that have been destroyed by radiation
      therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune
      response against the body's normal tissues. Mycophenolate mofetil and tacrolimus may be an
      effective treatment for graft-versus-host disease caused by bone marrow transplantation.

      PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, tacrolimus, and
      mycophenolate mofetil plus bone marrow transplantation in treating patients with hematologic
      cancers.
    

Detailed description: 
      OBJECTIVES: I. Determine whether sustained engraftment of HLA identical sibling marrow can be
      achieved in patients treated with total body irradiation before transplant and tacrolimus and
      mycophenolate mofetil after transplant. II. Document the nonhematologic toxicities of this
      regimen. III. Characterize immune reconstitution of patients during this treatment regimen.
      IV. Document the incidence of aplasia and graft-versus-host disease associated with donor
      leukocyte infusions when administered after this regimen.

      OUTLINE: Patients receive total body irradiation in a single fraction on day -1. Tacrolimus
      is given orally twice per day on days -1 to 50. Mycophenolate mofetil is given orally on day
      0 and twice per day on days 1 to 28. Patients receive donor bone marrow infusion on day 0.
      Patients are evaluated on days 56, 180, 292, and 365. If there is donor engraftment, donor
      chimerism is less than 80%, there is no active graft-versus-host disease, no disease
      progression, less than 50% decrease in donor cell chimerism from last measurement, and the
      patient is not taking immunosuppressive agents, then donor leukocyte infusions are
      administered on days 70, 194, and 306. Patients are followed annually for 5 years.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): peripheral blood lymphocyte therapy; mycophenolate mofetil; tacrolimus; allogeneic bone marrow transplantation; radiation therapy
Intervention type(s): Biological; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Primary purpose: Treatment
Keywords: stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; recurrent adult Hodgkin lymphoma; Waldenstrom macroglobulinemia; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; chronic phase chronic myelogenous leukemia; adult acute myeloid leukemia in remission; adult acute lymphoblastic leukemia in remission; stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage I grade 3 follicular lymphoma; stage I adult diffuse small cleaved cell lymphoma; stage I adult diffuse mixed cell lymphoma; stage I adult diffuse large cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage I adult lymphoblastic lymphoma; stage I adult Burkitt lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage III adult Burkitt lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV adult Burkitt lymphoma; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; stage I mantle cell lymphoma; contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II adult diffuse small cleaved cell lymphoma; contiguous stage II mantle cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult Burkitt lymphoma; contiguous 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 adult diffuse small cleaved cell lymphoma; noncontiguous stage II mantle cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; noncontiguous stage II small lymphocytic lymphoma; noncontiguous stage II marginal zone lymphoma; stage I marginal zone lymphoma; stage I small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone lymphoma; contiguous stage II marginal zone lymphoma; contiguous stage II small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma