Myelodysplastic Syndrome Clinical Trial
Official title:
Natural Killer Cells in Allogeneic Cord Blood Transplantation
This phase I trial studies the side effects and best way to give natural killer cells and donor umbilical cord blood transplant in treating patients with hematological malignancies. Giving chemotherapy with or without total body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer 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.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and safety of ex-vivo expanded cord blood (CB) natural killer
(NK) cells with double CB transplantation in patients with hematological malignancies.
SECONDARY OBJECTIVES:
I. To monitor engraftment, chimerism, graft versus host disease, and immune reconstitution in
patients receiving expanded CB NK cell therapy.
II. To estimate the time to platelet recovery and the time to absolute neutrophil count (ANC)
recovery.
III. To estimate overall survival and disease free survival at one year. IV. To study the
in-vivo persistence of cord blood NK cells.
OUTLINE:
PREPARATIVE REGIMEN: Patients are assigned to 1 of 2 treatment plans:
TREATMENT PLAN 1: Patients receive high-dose lenalidomide orally (PO) once daily (QD) on days
-8 to -2, fludarabine phosphate IV over 1 hour on days -7 to -4, and melphalan IV over 30
minutes on day -4. CD20 positive patients also receive rituximab intravenously (IV) over 6
hours on days -8 to -4.
TREATMENT PLAN 2: Patients receive high-dose lenalidomide PO QD on days -7 to -2,
cyclophosphamide IV over 3 hours on day -7, and undergo total body irradiation (TBI) on day
-3. Patients also receive rituximab and fludarabine phosphate as in Treatment Plan 1.
NK CELL INFUSION: All patients receive ex-vivo expanded cord blood NK cells IV over 30
minutes on day -2.
TRANSPLANT: All patients undergo allogeneic umbilical cord blood transplant on day 0.
GRAFT-VERSUS-HOST DISEASE (GVHD) PROPHYLAXIS: All patients receive tacrolimus IV or PO on
days -2 to 180 followed by taper and mycophenolate mofetil IV over 2 hours or PO thrice daily
(TID) on days -3 to 100.
After completion of study treatment, patients are followed up at 3, 6, and 12 months.
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