Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Condition: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Erythroleukemia (M6a); Adult Nasal Type Extranodal NK/T-cell Lymphoma; Adult Pure Erythroid Leukemia (M6b); B-cell Adult Acute Lymphoblastic Leukemia; B-cell Childhood Acute Lymphoblastic Leukemia; Blastic Phase Chronic Myelogenous Leukemia; Burkitt Lymphoma; Childhood Acute Erythroleukemia (M6); Childhood Acute Lymphoblastic Leukemia in Remission; Childhood Acute Megakaryocytic Leukemia (M7); Childhood Acute Minimally Differentiated Myeloid Leukemia (M0); Childhood Acute Monoblastic Leukemia (M5a); Childhood Acute Monocytic Leukemia (M5b); Childhood Acute Myeloid Leukemia in Remission; Childhood Chronic Myelogenous Leukemia; Childhood Diffuse Large Cell Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; Childhood Myelodysplastic Syndromes; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Chronic Myelomonocytic Leukemia; Chronic Phase Chronic Myelogenous Leukemia; Cutaneous B-cell Non-Hodgkin Lymphoma; de Novo Myelodysplastic Syndromes; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Juvenile Myelomonocytic Leukemia; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Nodal Marginal Zone B-cell Lymphoma; Previously Treated Myelodysplastic Syndromes; Prolymphocytic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult 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 Grade III Lymphomatoid Granulomatosis; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Small Noncleaved Cell 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 Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Relapsing Chronic Myelogenous Leukemia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Secondary Myelofibrosis; Splenic Marginal Zone Lymphoma; Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia; T-cell Adult Acute Lymphoblastic Leukemia; T-cell Childhood Acute Lymphoblastic Leukemia; T-cell Large Granular Lymphocyte Leukemia; Waldenstrom Macroglobulinemia
MeSH terms: Burkitt Lymphoma; Mycoses; Lymphoma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Preleukemia; Neoplasm Metastasis; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, B-Cell, Marginal Zone; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, Large B-Cell, Diffuse; Hematologic Neoplasms; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Mycosis Fungoides; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous; Waldenstrom Macroglobulinemia; Leukemia, Myelomonocytic, Juvenile; Lymphoma, Large-Cell, Anaplastic; Leukemia, Myeloid, Chronic-Phase; Blast Crisis; Lymphomatoid Granulomatosis; Lymphoma, Extranodal NK-T-Cell; Leukemia, Prolymphocytic; Leukemia, Monocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Large Granular Lymphocytic; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) helps
      stop the growth of cancer and abnormal cells and helps stop the patient's immune system from
      rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not
      exactly match the patient's blood, 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 antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil
      after transplant may stop this from happening.

      PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell
      transplant works in treating patients with hematologic malignancies.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      1. To establish the day +180 overall survival after a myeloablative unrelated double unit
      UCBT in a single institution setting.

      SECONDARY OBJECTIVES:

        1. To determine the rates of hematologic and immune reconstitution in patients with high
           risk hematologic malignancies, who are undergoing myeloablative chemotherapy followed by
           infusion of double unit UCBT.

        2. To determine the contribution of each umbilical cord unit to immune reconstitution with
           a focus on both initial (day +21 BM, and +28 PB) and sustained engraftment (day +100 BM;
           PB at +14, +21, +28, +35, +42, +60, +100, +180, +1 and 2 years).

        3. To determine the probability of overall survival and disease free survival at one and
           two years.

        4. To describe the incidence of disease recurrence at one and two years in patients post
           UCBT.

        5. To describe the incidence of acute GVHD and chronic GVHD at 100 days and at one year,
           respectively.

        6. To determine the incidence of day 100 and 180 treatment related mortality.

        7. To determine the incidence of serious infectious complications in the first year after
           transplant.

        8. To determine the incidence of donor-derived neutrophil and platelet recovery.

        9. To determine the incidence of secondary lymphoproliferative diseases following
           transplantation with umbilical cord blood.

      OUTLINE:

      PREPARATIVE REGIMEN: Patients receive oral busulfan every 6 hours on days -8 to -5,
      cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on
      days -3 to -1.

      TRANSPLANTATION: Patients undergo double-unit umbilical cord blood allogeneic stem cell
      transplantation on day 0.

      GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and
      taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally every 8
      hours on days -3 to 45. After completion of study treatment, patients are followed
      periodically.
    

Intervention name(s): double-unit umbilical cord blood transplantation; cytogenetic analysis; bone marrow aspiration; fluorescence in situ hybridization; busulfan; cyclophosphamide; anti-thymocyte globulin; methylprednisolone; cyclosporine; mycophenolate mofetil; flow cytometry; allogeneic hematopoietic stem cell transplantation
Intervention type(s): Procedure; Other; Procedure; Other; Drug; Drug; Drug; Drug; Drug; Drug; Other; Procedure
Intervention description(s): Undergo transplantation; Correlative studies; Correlative studies; Correlative studies; Given orally; Given IV; Given IV; Given IV; Given IV; Given orally or IV; Correlative studies; Undergo transplantation
Other intervention name(s): fluorescence in situ hybridization (FISH); BSF; BU; Misulfan; Mitosan; Myeloleukon; Myelosan; CPM; CTX; Cytoxan; Endoxan; Endoxana; Enduxan; ATG; ATGAM; lymphocyte immune globulin; Thymoglobulin; A-MethaPred; Depo-Medrol; Medrol; MePRDL; Solu-Medrol; Wyacort; 27-400; ciclosporin; cyclosporin; cyclosporin A; CYSP; Sandimmune; Cellcept; MMF
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Cyclophosphamide; Busulfan; Cyclosporins; Thymoglobulin; Antilymphocyte Serum; Prednisolone hemisuccinate; Prednisolone phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment