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MT2021-08 T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Blood Cancers

This study is testing a new way to perform a stem cell transplant for people with certain blood cancers (hematologic malignancies), including acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). It uses a special type of transplant called T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation. Researchers want to see how often a complication called GVHD (Graft-versus-Host Disease) occurs after this type of transplant. You might receive medicines like Fludarabine, Busulfan, Melphalan, Rituximab, and Levetiracetam as part of the treatment. The study is open to children and adults up to 60 years old who have been diagnosed with these specific blood cancers.

Study design
This is a Phase 2, open-label study, meaning both you and the study team will know which treatments you are receiving. It plans to enroll 70 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will determine the rate of GVHD after the transplant, measured at 100 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05735717

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

Recruiting
PHASE2Up to 60InterventionalTreatment
Masonic Cancer Center, University of Minnesota
~70 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:FludarabineBusulfanMelphalanRituximabLevetiracetamAlpha/Beta T Cell-Depleted Hematopoietic Stem Cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the rate of GVHD after alpha beta TCR depletion
Measured over 100 days

Conditions

Hematologic 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

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaHematologic NeoplasmHigh Grade Adult Non-Hodgkin's LymphomaLymphoblastic LymphomaMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Margaret MacMillan · PRINCIPAL_INVESTIGATOR · Masonic Cancer Center, University of Minnesota

Who to contact

Margaret MacMillan
[email protected]
612-626-2961
Email the study team

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Eligibility criteria

Inclusion

Histological confirmation of hematological malignancies
Acute leukemias
Acute Myeloid Leukemia (AML) and related precursor neoplasms
Favorable risk AML is defined as having one of the following:
Acute lymphoblastic leukemia (ALL)/lymphoma
Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.
Age 60 years of age or younger at the time of consent
Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.
Adequate organ function

Exclusion

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
CML blast crisis
Active central nervous system malignancy

What this trial measures

  • Determine the rate of GVHD after alpha beta TCR depletion100 days

    GVHD incidence after treatment.