Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Lymphocytic Leukemia
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Hodgkin Lymphoma
- Acute Biphenotypic Leukemia
- Acute Leukemia
- Myelodysplastic Syndrome
- Therapy-Related Myelodysplastic Syndrome
- Refractory Myelodysplastic Syndrome
- Small Lymphocytic Lymphoma
- Acute Lymphoblastic Leukemia
- Acute Lymphoblastic Leukemia in Remission
- Acute Myeloid Leukemia
- Langerhan's Cell Histiocytosis
- Refractory Acute Lymphoblastic Leukemia
- Non Hodgkin Lymphoma
- Recurrent Hodgkin Lymphoma
- Minimal Residual Disease
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Chemotherapy-Related Leukemia
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndrome With Excess Blasts
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 65 years
- Gender
- Both males and females
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 mali...
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. OUTLINE: Patients are assigned to 1 of 3 groups. GROUP I: Patients receive rituximab intravenously (IV) on day -11, anti-thymocyte globulin (ATG) IV over 4 hours on days -9 and -8, fludarabine IV over 1 hour, clofarabine IV over 1 hour, busulfan IV over 3 hours on days -7 through -4, and total body irradiation (TBI) on day -3. Patients then receive a cord blood transfusion IV on day 0. GROUP II: Patients receive ATG IV over 4 hours on days -8 and -7, fludarabine IV over 30 minutes on days -5 to -2, and melphalan IV over 30 minutes on day -2. Patients then receive a cord blood transplant IV on day 0. GROUP III: Patients receive ATG IV over 4 hours on days -8 and -7, fludarabine IV over 30 minutes on days -6 to -3, cyclophosphamide IV over 1 hour on day -6, and one low-dose treatment of TBI on day -1. Patients then receive a cord blood transplant IV on day 0. GVHD PROPHYLAXIS: All patients also 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.
Tracking Information
- NCT #
- NCT03096782
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Amanda Olson M.D. Anderson Cancer Center