Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

July 14, 2016

Primary Completion Date

July 1, 2025

Study Completion Date

July 1, 2026

Conditions
Acute Lymphoblastic Leukemia (ALL)Acute Myeloid Leukemia (AML)Myeloid SarcomaChronic Myeloid Leukemia (CML)Juvenile Myelomonocytic Leukemia (JMML)Myelodysplastic Syndrome (MDS)Non-Hodgkin Lymphoma (NHL)
Interventions
DRUG

Anti-thymocyte globulin (rabbit)

Given intravenous (IV) prior to transplant on Days -14, -13, -12.

DRUG

Blinatumomab

Given by continuous IV infusion at least 2 weeks post-engraftment. Blinatumomab will be given only to patients with CD19+ malignancies.

DRUG

Cyclophosphamide

Given by IV infusion prior to transplant on Day -9.

DRUG

Fludarabine

Given IV prior to transplant on Days -8, -7, -6, -5, and -4.

DRUG

G-CSF

Given IV or subcutaneous (SQ) following transplant on Days 6 and 7.

DRUG

Melphalan

Given IV prior to transplant on Days -2 and -1.

DRUG

Mesna

Given IV prior to cyclophosphamide administration and at approximately 3, 6, and 9 hours after cyclophosphamide infusion.

DRUG

Rituximab

Given IV prior to transplant on Day -1.

DRUG

Tacrolimus

Given oral (PO) or IV beginning prior to transplant on Day -2. The dose will begin to taper at approximately day +60 after transplant in the absence of GVHD. Tacrolimus was used for the first 5 participants enrolled on study. Subsequent participants receive sirolimus.

DRUG

Thiotepa

Given IV prior to transplant on Day -3.

BIOLOGICAL

HPC,A Infusion

Hematopoietic Progenitor Cell, Apheresis (HPC,A) infusion of TCRɑβ+ depleted cells on day of transplant (Day 0) and HPC,A infusion of CD45RA+ depleted cells on Day +1 following transplant.

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

Sirolimus

Given orally (PO) starting Day 0. The dose will be tapered off over two weeks starting on Day +42 in the absence of GVHD.

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER