Study on Brexucabtagene Autoleucel for Patients with Relapsed/Refractory and Newly Diagnosed B-cell Acute Lymphocytic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06287229

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment, brexucabtagene autoleucel, for patients with B-cell Acute Lymphocytic Leukemia (ALL) that has returned or not responded to previous treatments, as well as for those newly diagnosed with high-risk B-cell ALL.

Patient Parameters

Program Overview

The study aims to determine if brexucabtagene autoleucel, a type of CAR-T cell therapy, is safe and can help control B-cell Acute Lymphocytic Leukemia (ALL) in patients whose cancer has returned or not responded to previous treatments. It also explores its use in newly diagnosed high-risk patients after initial treatments with specific chemotherapy drugs.

Description

The main goal of this study is to see how well brexucabtagene autoleucel, a CAR-T cell therapy, works in patients with relapsed or refractory B-cell ALL and those newly diagnosed with high-risk B-cell ALL. Researchers will measure how long patients stay free from cancer progression and overall survival rates at different time points. They will also look at how long patients remain free of minimal residual disease (MRD), which is a small number of cancer cells that might remain after treatment.

The study will also monitor the safety of the treatment and how well patients respond, including complete remission rates. Researchers will explore how the CAR-T cells expand in the body, the effect on B-cells, and other immune system factors over time. Additional samples will be collected to study the tumor and immune system responses in more detail.

Participants will undergo regular assessments, including blood tests and scans, to monitor their health and the treatment's effectiveness. The study will provide valuable insights into whether this new approach can offer better outcomes for patients with B-cell ALL.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older with relapsed or refractory B-cell ALL.
  • Newly diagnosed adults aged 18 years or older with high-risk B-cell ALL, including specific genetic markers or abnormalities.
  • Good overall health with a performance status score of 0, 1, or 2.
  • Adequate organ function, including specific levels of kidney and liver function.
  • Cancer cells must show CD19 expression.
  • Patients with controlled chronic viral infections like Hepatitis B, Hepatitis C, or HIV are eligible if they are on treatment and the infection is under control.

Exclusion Criteria

  • Patients with Philadelphia positive B-cell ALL.
  • Women who are pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test.
  • Previous treatment with brexucabtagene autoleucel or other anti-CD19 CAR-T cell therapies.
  • Active and uncontrolled disease or infection as determined by the doctor.
  • Inability or unwillingness to sign the consent form.
  • Participation in another investigational therapy within the past 14 days.

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