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Trial Title: 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

NCT ID: NCT06287229

Condition: Relapsed/Refractory
B-cell Acute Lymphocytic Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Blinatumomab
Inotuzumab Ozogamicin

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Blinatumomab
Description: Given by Infusion
Arm group label: Phase 1B + Phase 2

Intervention type: Drug
Intervention name: Inotuzumab Ozogamicin
Description: Given by IV
Arm group label: Phase 1B + Phase 2

Intervention type: Drug
Intervention name: Hyper-CVAD
Description: Given by IV Participants younger than 60 years of age, you will receive hyper-CVAD.
Arm group label: Phase 1B + Phase 2

Intervention type: Drug
Intervention name: Mini-hyper-CVD
Description: Given by IV Participants 60 years of age or older, you will receive mini-hyper-CVD
Arm group label: Phase 1B + Phase 2

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.

Detailed description: Primary Objectives: To assess the Efficacy of Brexucabtagene autoleucel [anti-CD19 autologous derived chimeric antigen receptor T-cell (CAR-T)] in terms of EFS in patients with R/R and high-risk newly diagnosed B-cell acute lymphoblastic leukemia (B-cell ALL) post cytoreduction with mini-hyper-CVD-inotuzumab-blinatumomab/Hyper-CVAD-inotuzumab-blinatumomab The EFS will be estimated in terms of median EFS and 9-month EFS for the R/R cohort and 18-month EFS for the frontline cohort. Secondary Objectives: 1. 12 and 24-months overall survival (OS): 12 months for the R/R cohort and 24 months for the frontline cohort 2. Duration of persistent MRD negativity by flow cytometry and NGS at 9 and 18 months: 9 months for the R/R cohort and 18 months for the frontline cohort 3. Best Ooverall response rates [complete remission (CR) and CR with incomplete count recovery (CRi)] 4. Achievement of MRD negativity amongst patients in CR and not MRD negative before Brexucabtagene autoleucel infusion 5. Safety Exploratory Objectives: 1. CAR-T-cell expansion ((Days 1, 4, 8, 11, 14, 21, 28, monthly up to 3 months and then every 3 months up to 24 months post infusion) 2. B-cell aplasia (Days 0, 7, 14, 28, monthly up to 3 months and then every 3 months up to 24 months post infusion) 3. Measurable residual disease (MRD) negativity by next-generation sequencing (NGS) (at 1 in 105-6 sensitivity) (PB on D14 and PB/BM: Day 28, and then Q3 months up to 24 months post infusion) 4. Cytokine panel (Days 0, 1, 2, 4, 7, 10, 14, 28) 5. Additional correlatives samples to address tumor samples and immune system factors will be collected at baseline, D28 and Q3 months. These include samples for bulk RNA sequencing of the tumor and germline and single cell RNA sequencing of CAR T-cells as also for assessing the methylation signatures of the CAR T-cells.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Elias Jabbour, MD

Phone: 713-792-4764
Email: ejabbour@mdanderson.org

Investigator:
Last name: Elias Jabbour, MD
Email: Principal Investigator

Start date: July 11, 2024

Completion date: December 31, 2030

Lead sponsor:
Agency: M.D. Anderson Cancer Center
Agency class: Other

Source: M.D. Anderson Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06287229
http://www.mdanderson.org

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