Study Overview

Study Details

Study overview

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

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

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

Condition
Hematologic Malignancy
Intervention / Treatment

-

Contacts and Locations

Minneapolis

University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Masonic Cancer Center, University of Minnesota,

Margaret MacMillan, PRINCIPAL_INVESTIGATOR, University of Minnesota Masonic Cancer Center

Study Record Dates

2030-11-30