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

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.

Trial Details

NCT ID

NCT06287229

Phase

PHASE1 / PHASE2

Sponsor

M.D. Anderson Cancer Center

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Blinatumomab
Inotuzumab Ozogamicin
Hyper-CVAD
Mini-hyper-CVD

Locations (sample)

Houston, Texas, United States|29.76328,-95.36327

Key Eligibility 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:
KMT2A rearranged ALL
Complex cytogenetics as per NCCN 2022

For full eligibility, visit ClinicalTrials.gov.

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