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

ConditionsRelapsed/Refractory B-cell Acute Lymphocytic Leukemia

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants of age ≥18 years with documented relapsed or refractory B-cell ALL

KMT2A rearranged ALL

Complex cytogenetics as per NCCN 2022

Low-hypodiploidy/tetraploidy

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Blinatumomab
Drug
Given by Infusion
Inotuzumab Ozogamicin
Drug
Given by IV
Hyper-CVAD
Drug
Given by IV Participants younger than 60 years of age, you will receive hyper-CVAD.
Mini-hyper-CVD
Drug
Given by IV Participants 60 years of age or older, you will receive mini-hyper-CVD

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Phase 1B + Phase 2Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

Safety and adverse events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame

Through study completion; an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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