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

ConditionsHematologic Malignancy Acute Leukemia Remission Acute Myeloid Leukemia Acute Lymphoblastic Leukemia AML TP53 Intrachromosomal Amplification of Chromosome 21 Cytogenetic Abnormality CNS Leukemia Minimal Residual Disease Myelodysplasia Juvenile Myelomonocytic Leukemia Somatic Mutation PTPN11 Gene Mutation N-RAS Gene Amplification Neurofibromatosis 1 NF1 Mutation CBL Gene Mutation Monosomy 7 Chromosome Abnormality Fetal Hemoglobin Lymphoblastic Lymphoma High Grade Non-Hodgkin's Lymphoma, Adult

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

AgeUp to 60

SponsorMasonic Cancer Center, University of Minnesota

About this trial

This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety/feasibility study of the investigational procedure/product.

Eligibility criteria

Qualifiers

Histological confirmation of hematological malignancies

Acute leukemias

Acute Myeloid Leukemia (AML) and related precursor neoplasms

Acute lymphoblastic leukemia (ALL)/lymphoma

Disqualifiers

Pregnant or breastfeeding.

Active uncontrolled infection within 1 week of starting preparative therapy

Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.

Any prior autologous or allogeneic transplant

Trial design

Treatments tested in this trial

Fludarabine
Busulfan
Melphalan
Rituximab
Levetiracetam
Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells
Thymoglobulin
Cyclophosphamide

Treatment groups

70 Participants

are divided into 8 treatment groups

Treatment groups

See each treatment group below.

Sponsors and collaborators

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov