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Brexucabtagene Autoleucel for B-Cell Leukemia

Phase 1 & 2

Recruiting

Led By Elias Jabbour, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of giving the drug brexucabtagene autoleucel to participants with B-cell ALL who have not responded well to other treatments. The goal is

Who is the study for?

This trial is for patients with B-cell Acute Lymphocytic Leukemia (ALL) who have either not responded to previous treatments or are newly diagnosed and at high risk. Participants must have completed treatment with inotuzumab ozogamicin, blinatumomab, and hyper-CVAD or mini-hyper-CVD.

What is being tested?

The study is testing the safety and effectiveness of brexucabtagene autoleucel as a follow-up therapy in controlling B-cell ALL after initial treatment with inotuzumab ozogamicin, blinatumomab, and hyper-CVAD/mini-hyper-CVD regimens.

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related symptoms like fever or chills, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Each patient's experience may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase 1B + Phase 2Experimental Treatment4 Interventions

Participants found to be eligible to take part in this study, you will be assigned to a study phase (Phase 1B or Phase 2). Up to 10 participants will be enrolled in Phase 1B, and up to 30 will be enrolled in Phase 2. All participants will first receive cytoreductive therapy (inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD), followed by lymphodepletion chemotherapy and 1 dose of brexucabtagene autoleucel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inotuzumab Ozogamicin

2011

Completed Phase 2

~360

Blinatumomab

2014

Completed Phase 3

~1230