Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma
Condition: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Acute Biphenotypic Leukemia; Acute Leukemia; Acute Lymphoblastic Leukemia; Acute Lymphoblastic Leukemia in Remission; Acute Myeloid Leukemia; Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Chemotherapy-Related Leukemia; Chronic Lymphocytic Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Myelomonocytic Leukemia; Hodgkin Lymphoma; Langerhans Cell Histiocytosis; Minimal Residual Disease; Myelodysplastic Syndrome; Myelodysplastic Syndrome With Excess Blasts; Non-Hodgkin Lymphoma; Recurrent Hodgkin Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Myelodysplastic Syndrome; Small Lymphocytic Lymphoma; Therapy-Related Myelodysplastic Syndrome
MeSH terms: Lymphoma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Hodgkin Disease; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Neoplasm, Residual; Leukemia, Myeloid, Accelerated Phase; Leukemia, Biphenotypic, Acute; Histiocytosis, Langerhans-Cell; Myelodysplastic Syndromes; Histiocytosis; Anemia, Refractory, with Excess of Blasts; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well an umbilical cord blood transplant with added sugar
      works with chemotherapy and radiation therapy in treating patients with leukemia or lymphoma.
      Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant
      helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem
      cells) and cancer cells. When the healthy 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. The umbilical cord blood cells will be grown ("expanded") on a special
      layer of cells collected from the bone marrow of healthy volunteers in a laboratory. A type
      of sugar will also be added to the cells in the laboratory that may help the transplant to
      "take" faster.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To evaluate the safety and feasibility of transplantation of cord blood which is expanded
      in mesenchymal precursor cell (MPC) co-cultures then fucosylated with fucosyltransferase
      (FT)-VI and guanosine diphosphate (GDP) fucose prior to infusion in patients with hematologic
      malignancies following high-dose therapy.

      II. To evaluate the time to engraftment using expanded fucosylated cord blood.

      SECONDARY OBJECTIVES:

      I. To evaluate the rate and severity of graft versus host disease. II. To evaluate the rates
      of infectious complications. III. To evaluate the rates of disease-free and overall survival.

      Summary: All patients receive Busulfan as per standard of care. Busulfan test dose can be
      administered either as an outpatient prior to admission or as an inpatient on Day -10.

      Busulfan pharmacokinetics will be performed with the test dose and the first dose on Day -7
      per standard of care. The doses of Days -6, -5, and -4 will be subsequently adjusted to
      target an AUC of 4,000 microMol.min-1. In the event that PK adjusting were not possible a
      dose of busulfan of 130 mg/m2 will be administered.

      GVHD PROPHYLAXIS: All patients receive mycofenolate mofetil IV over 2 hours or orally (PO)
      twice daily (BID) on days -3 with a taper beginning on day 100 in the absence of GVHD,
      tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and
      filgrastim-sndz subcutaneously (SC) once daily (QD) starting on day 0 until white blood count
      begins to recover.

      After completion of study treatment, patients are followed up at months 1, 3, 6, and 12.
    

Intervention name(s): Anti-Thymocyte Globulin; Busulfan; Clofarabine; Cyclophosphamide; Filgrastim-sndz; Fludarabine; Melphalan; Mycophenolate Mofetil; Rituximab; Tacrolimus; Total-Body Irradiation; Umbilical Cord Blood Transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Biological; Drug; Drug; Drug; Biological; Drug; Radiation; Procedure
Intervention description(s): Given IV; Given IV; Given IV; Given IV; Given SC; Given IV; Given IV; Given IV or PO; Given IV; Given IV; Undergo total body irradiation; Undergo cord blood transplant
Other intervention name(s): Antithymocyte Globulin; Antithymocyte Serum; ATG; ATGAM; ATS; Thymoglobulin; 1, 4-Bis[methanesulfonoxy]butane; BUS; Bussulfam; Busulfanum; Busulfex; Busulphan; CB 2041; CB-2041; Glyzophrol; GT 41; GT-41; Joacamine; Methanesulfonic Acid Tetramethylene Ester; Methanesulfonic acid, tetramethylene ester; Mielucin; Misulban; Misulfan; Mitosan; Myeleukon; Myeloleukon; Myelosan; Mylecytan; Myleran; Sulfabutin; Tetramethylene Bis(methanesulfonate); Tetramethylene bis[methanesulfonate]; WR-19508; Clofarex; Clolar; (-)-Cyclophosphamide; 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate; Carloxan; Ciclofosfamida; Ciclofosfamide; Cicloxal; Clafen; Claphene; CP monohydrate; CTX; CYCLO-cell; Cycloblastin; Cycloblastine; Cyclophospham; Cyclophosphamid monohydrate; Cyclophosphamidum; Cyclophosphan; Cyclophosphane; Cyclophosphanum; Cyclostin; Cyclostine; Cytophosphan; Cytophosphane; Cytoxan; Fosfaseron; Genoxal; Genuxal; Ledoxina; Mitoxan; Neosar; Revimmune; Syklofosfamid; WR- 138719; Filgrastim Biosimilar Filgrastim-sndz; Zarxio; Fluradosa; Alanine Nitrogen Mustard; CB-3025; L-PAM; L-Phenylalanine Mustard; L-sarcolysin; L-Sarcolysin Phenylalanine mustard; L-Sarcolysine; Melphalanum; Phenylalanine Mustard; Phenylalanine nitrogen mustard; Sarcoclorin; Sarkolysin; WR-19813; Cellcept; MMF; ABP 798; BI 695500; C2B8 Monoclonal Antibody; Chimeric Anti-CD20 Antibody; CT-P10; IDEC-102; IDEC-C2B8; IDEC-C2B8 Monoclonal Antibody; MabThera; Monoclonal Antibody IDEC-C2B8; PF-05280586; Rituxan; Rituximab Biosimilar ABP 798; Rituximab Biosimilar BI 695500; Rituximab Biosimilar CT-P10; Rituximab Biosimilar GB241; Rituximab Biosimilar IBI301; Rituximab Biosimilar PF-05280586; Rituximab Biosimilar RTXM83; Rituximab Biosimilar SAIT101; RTXM83; FK 506; Fujimycin; Hecoria; Prograf; Protopic; Total Body Irradiation; Whole-Body Irradiation; Cord Blood Transplantation; UCB transplantation
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Melphalan; Busulfan; Mechlorethamine; Nitrogen Mustard Compounds; Rituximab; Fludarabine; Clofarabine; Antineoplastic Agents, Immunological; Tacrolimus; Thymoglobulin; Antilymphocyte Serum; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment