Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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: Monoclonal antibodies such as daclizumab can locate tumor cells and either kill
      them or deliver tumor-killing substances to them without harming normal cells. Peripheral
      stem cell transplantation from a brother or sister may be effective treatment for hematologic
      cancer. Sometimes the transplanted cells can be rejected by the body's tissue. Mycophenolate
      mofetil, tacrolimus, and donor white blood cells may prevent this from happening.

      PURPOSE: Phase II trial to study the effectiveness of mycophenolate mofetil, tacrolimus,
      daclizumab, and donor peripheral stem cell transplantation in treating patients who have
      hematologic cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine whether donor hematopoiesis can be safely established using a
      nonmyeloablative conditioning regimen followed by HLA matched sibling donor peripheral blood
      stem cell transplantation in patients with hematologic malignancies. II. Determine whether
      mixed chimerism can be safely converted to full donor hematopoiesis with this treatment
      regimen in these patients. III. Determine the toxicity and incidence of aplasia and graft
      versus host disease in these patients treated with this regimen. IV. Determine the antitumor
      potential of this treatment regimen in these patients. V. Determine the role of NFkB in the
      modulation of the cytokine secretion profile of T lymphocytes during an alloimmune response
      in these patients treated with this regimen.

      OUTLINE: Patients receive immunosuppressive medications consisting of oral mycophenolate
      mofetil and tacrolimus twice a day beginning on day -8 and continuing through day 45 (in the
      absence of graft versus host disease). Patients also receive daclizumab IV over 30 minutes on
      days -1, 3, and 8. Patients undergo allogeneic peripheral blood stem cell (PBSC)
      transplantation with donor CD34+ cells IV on day 0. If there is 0-80% donor hematopoiesis,
      patients receive donor lymphocyte infusions with CD3+ cells IV on days 75, 165, and 270.

      PROJECTED ACCRUAL: A total of 10-45 patients will be accrued for this study.
    

Intervention name(s): daclizumab; therapeutic allogeneic lymphocytes; mycophenolate mofetil; tacrolimus; peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Drug; Drug; Procedure
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus; Daclizumab
Primary purpose: Treatment
Keywords: recurrent adult Hodgkin lymphoma; refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; relapsing chronic myelogenous leukemia; refractory chronic lymphocytic leukemia; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; meningeal chronic myelogenous leukemia; adult acute myeloid leukemia in remission; adult acute lymphoblastic leukemia in remission; 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 lymphoblastic lymphoma; stage IV adult Burkitt lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult Burkitt lymphoma; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; 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 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 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; recurrent mantle cell lymphoma; noncontiguous stage II small lymphocytic lymphoma; noncontiguous stage II marginal zone lymphoma; recurrent marginal zone lymphoma; recurrent 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