TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

January 31, 2019

Primary Completion Date

August 7, 2024

Study Completion Date

August 7, 2025

Conditions
Acute Lymphoblastic Leukemia (ALL)Acute Myeloid Leukemia (AML)Myelodysplastic Syndromes (MDS)NK-Cell LeukemiaHodgkin LymphomaNon Hodgkin Lymphoma (NHL)Juvenile Myelomonocytic Leukemia (JMML)Chronic Myeloid Leukemia (CML)
Interventions
DRUG

Cyclophosphamide

"Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.~intravenously (IV) once daily (QD) on day -9"

BIOLOGICAL

Fludarabine

"Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis.~fludarabine phosphate IV QD on days -8 to -4"

DRUG

Thiotepa

Thiotepa is a cell-cycle nonspecific polyfunctional alkylating agent.

DRUG

Melphalan

"Melphalan, a derivative of nitrogen mustard, is a bifunctional alkylating agent. Melphalan is active against tumor cells that are actively dividing or at rest.~melphalan IV QD on days -2 to -1"

BIOLOGICAL

G-csf

G-csf (granulocytic colony stimulating factor), is a biosynthetic hematopoietic agent that is made using recombinant DNA technology in cultures of Escherichia coli. G-CSF stimulates production, maturation and activation of neutrophils. In addition, endogenous G-CSF enhances certain functions of mature neutrophils, including phagocytosis, chemotaxis and antibody--dependent cellular cytotoxicity.

DRUG

Mesna

Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide. Following glomerular filtration, mesna disulfide is rapidly reduced in the renal tubules back to mesna, the active form of the drug.

DEVICE

CliniMACS

Cells for infusion are prepared using the CliniMACS

BIOLOGICAL

ATG (rabbit)

"Anti-thymocyte globulin is a purified, pasteurized, gamma immune globulin, obtained by immunization of rabbits with human thymocytes.~rabbit anti-thymocyte globulin IV daily over 6 hours on days -5 to -3,"

DRUG

Blinatumomab

"Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that mediates formation of a synapse between T cells and the CD19+ target cell, resulting in lysis of that CD19+ cell.Blinatumomab will be given to patients with a history of CD19+ malignancy as determined by St. Jude hematopathologist review of current and historical specimens and reports.~blinatumomab IV for 28 days beginning at least 1 week post-DLI"

BIOLOGICAL

TCRα/β+

IV on day 0 and may receive an additional dose on day 1

BIOLOGICAL

CD19+

IV on day 0 and may receive an additional dose on day 1

BIOLOGICAL

CD45RA-depleted DLI

infusion IV

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER

NCT03849651 - TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies | Biotech Hunter | Biotech Hunter