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Recruiting NCT05735717

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

Phase II Interventional Hematologic Malignancy Acute Leukemia Remission Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fludarabine, Busulfan, Melphalan, Rituximab.
Who it may be relevant to
Registry conditions: Hematologic Malignancy, Acute Leukemia, Remission, Acute Myeloid Leukemia. Basic parameters: up to 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies

Overview

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.

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

Primary outcome measures

  • Determine the rate of GVHD after alpha beta TCR depletion [Time frame: 100 days]
Secondary outcome measures (4)
  • Transplant engraftment [Time frame: 42 days]
  • Graft Failure [Time frame: 100 days]
  • Non-relapse mortality (NRM) [Time frame: 12 months]
  • Overall survival (OS) [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota Masonic Cancer Center — Minneapolis

Identifiers

NCT: NCT05735717 · 2021LS061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗