Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma

  • STATUS
    Not Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    25
  • sponsor
    M.D. Anderson Cancer Center
Updated on 23 May 2022
gonadotropin
cancer
remission
chronic myeloid leukemia
stem cell transplantation
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
hematologic malignancy
tacrolimus
anemia
mycophenolate mofetil
cyclophosphamide
chronic lymphocytic leukemia
tyrosine
chromosomal abnormalities
lymphoma
myelodysplastic syndromes
busulfan
anti-thymocyte globulin
hodgkin's disease
acute leukemia
white blood cell count
rituximab
umbilical cord blood transplantation
flow cytometry
chronic myelomonocytic leukemia
filgrastim
beta-human chorionic gonadotropin
hypodiploidy
ejection fraction
cytotoxic drug
melphalan
residual disease
pulmonary function test
leukemia
bone marrow procedure
lymphocytic leukemia
minimal residual disease
antithymocyte globulin
myeloproliferative syndromes
residual tumor
clofarabine
gleevec
blast cells
hydrea
white blood cells
human chorionic gonadotropin
progressive disease
blood transfusion
chemotherapy regimen
wbc count
myelomonocytic leukemia
complex karyotype
nucleated cells
beta human chorionic gonadotrophin
ibrutinib
blood cell count
chromosomal abnormality
chromosome abnormality
lymphocyte immune globulin
acute biphenotypic leukemia
autologous hematopoietic stem cell transplant

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.

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.

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.

Details
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
Treatment Rituximab, G-CSF, anti-thymocyte globulin, cyclophosphamide, mycophenolate mofetil, busulfan, melphalan, Fludarabine, Tacrolimus, Total-Body Irradiation, MESNA, Clofarabine, Total body irradiation, Umbilical Cord Blood Transplantation, Cord Blood Transplant, ATG, ATG, Mycofenolate mofetil, Filgrastim-sndz
Clinical Study IdentifierNCT03096782
SponsorM.D. Anderson Cancer Center
Last Modified on23 May 2022

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