Using Brexucabtagene Autoleucel to treat B-cell Acute Lymphoblastic Leukemia after initial therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of brexucabtagene autoleucel, a CAR-T cell therapy, in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) following treatment with inotuzumab ozogamicin and blinatumomab. The study aims to determine the event-free survival (EFS) rates and overall survival (OS) at various time points for both relapsed and newly diagnosed high-risk patients. Participants will be monitored for safety, response rates, and measurable residual disease (MRD) negativity. The trial includes both primary and exploratory objectives to assess the treatment's impact on disease control and patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants of age ≥18 years with documented relapsed or refractory B-cell ALL
* In the newly diagnosed cohort: Participants of age ≥18 years with high-risk newly diagnosed B-cell ALL defined as:

  1. KMT2A rearranged ALL
  2. Complex cytogenetics as per NCCN 2022
  3. Low-hypodiploidy/tetraploidy
  4. Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)
* Performance status of 0, 1, or 2
* Adequate organ function with creatinine less than or equal to 1.6 mg/dl, bilirubin less than or equal to 3.5 mg and ALT and AST less than or equal to 5 times institutional upper limit of normal
* Participants should be CD19 expression positive (\>50%) before enrollment
* Participants with chronic viral infections like Hepatitis B-virus, Hepatitis C virus or Human Immunodeficiency virus I/II will be eligible if they are on therapy and infections are under control.

Exclusion Criteria

* Philadelphia positive B-cell ALL
* Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization
* Prior exposure to brexu-cel or other anti-CD-19 CAR T cell therapy
* Active and uncontrolled disease/infection as judged by the treating physician
* Unable or unwilling to sign the consent form
* No other investigational therapy within the past 14 days

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Elias Jabbour, MD — M.D. Anderson Cancer Center
• Study coordinator: Elias Jabbour, MD
• Email: ejabbour@mdanderson.org
• Phone: (713) 792-4764

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining Blinatumomab and Venetoclax with Inotuzumab Ozogamicin for B-ALL Treatment

  This study is testing a new combination of three medications to see if it can help adults with newly diagnosed B-cell acute lymphoblastic leukemia live longer and healthier lives.

  Recruiting Phase 2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT06554626

• New treatment approach for pediatric patients with relapsed B-cell leukemia

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• Inotuzumab ozogamicin and blinatumomab with optional ponatinib for CD22-positive B-cell acute lymphoblastic leukemia

  This trial will test whether inotuzumab ozogamicin followed by blinatumomab, with or without ponatinib, can help people with CD22-positive B-cell acute lymphoblastic leukemia who are newly diagnosed, have relapsed, or are refractory to prior therapy.

  Recruiting at 89 sites Phase 2 National Cancer Institute (NCI) · Birmingham, Alabama and 284 other locations · NCT03739814

• Using blinatumomab, inotuzumab ozogamicin, and chemotherapy to treat B acute lymphoblastic leukemia

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  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT02877303

• Blinatumomab plus low-dose donor cells after transplant for high-risk B-ALL

  This small, early-phase study tests whether giving blinatumomab with low-dose donor lymphocytes after allogeneic transplant is safe and helps long-term survival for people with high-risk B-ALL.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07677878

• LP-118 in combination with standard therapy for newly diagnosed Ph+ ALL

  This study tests whether adding LP-118 to the standard therapy for adults with Philadelphia chromosome–positive ALL is safe and useful.

  Recruiting at 2 sites Phase 1 Wake Forest University Health Sciences · Charlotte, North Carolina and 1 other locations · NCT07614022

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.