Health Trials

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

ConditionsHematologic 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 HemoglobinLymphoblastic LymphomaHigh 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

8

Treatment groups

See each treatment group below.

Locations

1
University of Minnesota Masonic Cancer Center55455, MinneapolisMinnesota, United States

Sponsors and collaborators

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov