Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-24 @ 2:30 PM
NCT ID:
NCT07053059
Eligibility Criteria:
Inclusion Criteria:
I. Patients of age .18 years with high-risk B-cell ALL in first remission and \<5% BM blasts with at least one high-risk feature defined as:
a. Ph-negative B-cell ALL: i. KMT2A rearranged ALL ii. Complex cytogenetics as per NCCN 2022 iii. Low-hypodiploidy/tetraploidy iv. Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions) v. TP53 mutation (variant allele fraction \>2%) vi. Persistent MRD by flow cytometry and/or NGS b. Ph-positive B-cell ALL: i. IKZF1plus genotype (IKZF1 deletion coexisting with PAX5 or CDKN2A/2B, or PAR1 region deletions) or other high-risk features such as VPRB1 deletion, etc. ii. High WBC (\>30 x 109/L) at initial presentation iii. Persistent MRD by flow cytometry and/or NGS and/or PCR II. Performance status of 0, 1, or 2 III. 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 IV. Patients should be CD19 expression positive (\>1%) before enrollment VII. Patients with controlled CNS and/or other extramedullary leukemia will be eligible.
Exclusion Criteria:
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.
Patients with history of Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV) infections, even if under control. (Patients with Hepatitis B core antibody positive alone will not be an exclusion factor if HBV DNA PCR is negative).
Active and uncontrolled disease/infection as judged by the treating physician
Unable or unwilling to sign the consent form
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07053059
Study Brief:
Protocol Section:
NCT07053059