RECRUITING

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

Conditions

Relapsed/Refractory B-cell Acute Lymphocytic Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2024-07-11

Study Completion:2030-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06287229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.
* 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Elias Jabbour, MD

CONTACT

(713) 792-4764

ejabbour@mdanderson.org

Principal Investigator

Elias Jabbour, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Elias Jabbour, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-11

Study Completion Date2030-12-31

Study Record Updates

Study Start Date2024-07-11

Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

Relapsed/Refractory
B-cell Acute Lymphocytic Leukemia