MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies

PHASE2RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

May 11, 2023

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2030

Conditions
Hematologic MalignancyAcute LeukemiaRemissionAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaAMLTP53Intrachromosomal Amplification of Chromosome 21Cytogenetic AbnormalityCNS LeukemiaMinimal Residual DiseaseMyelodysplasiaJuvenile Myelomonocytic LeukemiaSomatic MutationPTPN11 Gene MutationN-RAS Gene AmplificationNeurofibromatosis 1NF1 MutationCBL Gene MutationMonosomy 7Chromosome AbnormalityFetal Hemoglobin
Interventions
DRUG

Fludarabine

Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.

DRUG

Busulfan

Busulfan 82.1 mg\*hr/L IV on days -5 to -2 or days -8 to -5

DRUG

Melphalan

Melphalan 50 mg/m2 IV on days -4 to -2

DRUG

Rituximab

200 mg/m2 intravenous given once on day-1

DRUG

Levetiracetam

As seizures have occurred following high dose busulfan, all patients will be treated with Keppra beginning day -6 and continuing until day -1 per institutional guidelines.

BIOLOGICAL

Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells

Patients will be treated on the most medically appropriate regimen followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.

DRUG

Thymoglobulin

rabbit anti-thymocyte globulin (rATG). Used in conditioning regimens for in vivo depletion of T cells, and the use of fludarabine model-based dosing to optimize dosing.

DRUG

Cyclophosphamide

Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2

Trial Locations (1)

55455

RECRUITING

University of Minnesota Masonic Cancer Center, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER