RecruitingPhase 1/2

Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab

United States40 participantsStarted 2024-07-11

Plain-language summary

To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. KMT2A rearranged ALL
✓. Complex cytogenetics as per NCCN 2022
✓. Low-hypodiploidy/tetraploidy
✓. Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)

What they're measuring

Safety and adverse events (AEs)

Timeframe: Through study completion; an average of 1 year

Trial details

NCT IDNCT06287229

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Elias Jabbour, MD

(713) 792-4764 ejabbour@mdanderson.org

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