Haploidentical Donor Hematopoietic Progenitor Cell and NK Cell Transplantation for Hematologic Malignancy

PHASE2CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

May 16, 2013

Primary Completion Date

August 27, 2021

Study Completion Date

September 27, 2021

Conditions
LeukemiaLymphoma
Interventions
RADIATION

Total Lymphoid Irradiation

Participants receive total lymphoid irradiation over four doses.

DRUG

Fludarabine

Given IV.

DRUG

Cyclophosphamide

Given IV.

DRUG

Thiotepa

Given IV.

DRUG

Melphalan

Given IV.

BIOLOGICAL

HPC,A Infusion

Participants received infusions of HPC,A (CD34+ selected) and HPC,A (CD45RA depleted).

BIOLOGICAL

TC-NK Infusion

Participants receive infusions of TC-NK.

BIOLOGICAL

G-CSF

"Participants receive G-CSF subcutaneously or intravenously.~Donors receive G-CSF subcutaneously during cell mobilization."

DRUG

Mesna

Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is generally given intravenously prior to and again at 3, 6 and 9 hours following each dose of cyclophosphamide.

DEVICE

CliniMACS

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.

DRUG

Mycophenolate mofetil

Given intravenously or orally.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
collaborator

Assisi Foundation

OTHER

lead

St. Jude Children's Research Hospital

OTHER

NCT01807611 - Haploidentical Donor Hematopoietic Progenitor Cell and NK Cell Transplantation for Hematologic Malignancy | Biotech Hunter | Biotech Hunter