Study on Depleting Alpha/Beta T Cells and CD19+ B Cells in Stem Cell Transplants for Patients with Blood Cancers

Sponsor: University of Florida

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05800210

This clinical trial is exploring a new method of preparing stem cell transplants by removing specific immune cells to treat patients with various blood cancers, including leukemia and lymphoma. The study aims to assess the safety and effectiveness of this approach.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new method in stem cell transplants for patients with certain blood cancers. This method involves removing specific immune cells, known as alpha/beta T cells and CD19+ B cells, from the donor stem cells before they are transplanted into the patient. The study will include patients with different types of leukemia, high-risk myelodysplastic syndrome, and lymphoma. The goal is to see if this approach can improve the outcomes of stem cell transplants.

Eligibility Criteria

Inclusion Criteria

  • Children, adolescents, and young adults (ages 6 months to 39 years) with specific blood cancers, including:
    • Acute Lymphocytic Leukemia (ALL) with high-risk features or in second remission and beyond.
    • Acute Myeloid Leukemia (AML) with certain genetic markers, in remission, or with minimal residual disease.
    • Juvenile Myelomonocytic Leukemia (JMML) in remission or with recurrence.
    • Chronic Myeloid Leukemia (CML) in remission.
    • High-risk Myelodysplastic Syndrome (MDS).
    • Hodgkin or Non-Hodgkin Lymphoma with a history of treatment failure or in partial or complete remission.
  • Must not have more than one active cancer at the time of joining the study.
  • Must have a suitable donor for stem cell donation, either a matched sibling, unrelated donor, or a partially matched related donor.
  • Must have a performance status score of 60% or higher, indicating the ability to carry out daily activities.
  • Must have adequate organ function, including lungs, kidneys, heart, and liver, as determined by specific medical tests.
  • Must provide written informed consent and agree to follow all study procedures.
  • Participants of childbearing potential must use effective contraception during the study and for 8 weeks after the last treatment.

Exclusion Criteria

  • Patients with uncontrolled infections.
  • Patients who have had a stem cell transplant in the last 6 months, unless it's a boost.
  • Patients with active moderate to severe graft-versus-host disease (GVHD).
  • Patients who have not followed medical care instructions in the past.
  • Individuals who are unwilling or unable to use contraception during the study and for 8 weeks after.
  • Pregnant or breastfeeding women.
  • Individuals with other medical conditions that could interfere with the study or increase the risk of complications.
  • Prisoners or individuals who are detained for treatment of psychiatric or physical illnesses.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.