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UnknownNCT01619761

NK Cells in Cord Blood Transplantation

Natural Killer Cells in Allogeneic Cord Blood Transplantation

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
13 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
75 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAllogeneic Hematopoietic Stem Cell TransplantationUndergo allogeneic umbilical cord blood transplant
DRUGCyclophosphamideGiven IV
DRUGFludarabine PhosphateGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGLenalidomideGiven PO
DRUGMelphalanGiven IV
DRUGMycophenolate MofetilGiven IV or PO
BIOLOGICALNatural Killer Cell TherapyGiven IV
BIOLOGICALRituximabGiven IV
DRUGTacrolimusGiven IV or PO
RADIATIONTotal-Body IrradiationUndergo TBI
PROCEDUREUmbilical Cord Blood TransplantationUndergo allogeneic umbilical cord blood transplant

Timeline

Start date
2013-05-03
Primary completion
2021-11-01
Completion
2021-11-01
First posted
2012-06-14
Last updated
2020-02-11

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT01619761. Inclusion in this directory is not an endorsement.