Chemotherapy Plus Biological Therapy Followed By 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
      Sometimes the transplanted cells are rejected by the body's normal tissues. Antithymocyte
      globulin may prevent this from happening.

      PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus biological therapy
      followed by peripheral stem cell transplantation in treating patients who have hematologic
      cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the effect of nonmyeloablative chemotherapy followed by allogeneic
      peripheral blood stem cell transplantation on hematopoietic recovery in patients with
      hematologic malignancies. II. Determine the toxicities of this regimen in these patients.
      III. Determine the frequency of mixed hematopoietic chimerism in these patients after this
      therapy. IV. Determine the efficacy and toxicity of donor leukocyte infusions at relapse in
      these patients. V. Determine the response rates and survival of these patients after this
      therapy. VI. Determine the immune reconstitution of patients undergoing this therapy.

      OUTLINE: Patients receive fludarabine IV over 30 minutes on days -9 to -5, cyclophosphamide
      IV over 1 hour on day -5, and antithymocyte globulin IV over 10 hours on days -5 to -2.
      Allogeneic peripheral blood stem cells are infused on day 0. Patients who achieve complete
      remission (CR) and then relapse or patients who achieve less than a CR before day 60 receive
      donor leukocyte infusions (DLI) over 30 minutes. DLI are repeated as necessary for persistent
      disease. Patients are followed at 1, 3, and 6 months, then at 1 and 2 years.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
    

Intervention name(s): anti-thymocyte globulin; cyclophosphamide; fludarabine phosphate; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Procedure
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Antilymphocyte Serum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; recurrent adult Hodgkin lymphoma; refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; refractory chronic lymphocytic leukemia; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; adult acute myeloid leukemia in remission; adult acute lymphoblastic leukemia in remission; refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; 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; 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; secondary acute myeloid leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent mantle cell 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; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma