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:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT04404660
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older Age 18 years or older
* ECOG performance status of 0 or 1
* Relapsed or refractory B cell ALL
* Patients with Ph+ ALL are eligible if intolerant to TKI, failed two lines of any TKI, or failed one line of second-generation TKI, or if TKI is contraindicated
* Documented CD19 positivity within 1 month of screening
* Phase Ib: Primary Cohort IA: Presence of ≥5% blasts in BM at screening
* Phase Ib: Exploratory Cohort IB: MRD-positive defined as ≥ 1e-4 and \<5% blasts in the BM at screening
* Phase II: Primary Cohort IIA: Presence of ≥5% blasts in BM at screening
* Phase II: Cohort IIB: ≥2nd CR or CRi with MRD-positive defined as ≥1e-3 by central ClonoSEQ® NGS testing and \<5% blasts in the BM at screening
* Adequate renal, hepatic, pulmonary, and cardiac function
Exclusion Criteria:
* Phase Ib (Cohort IA and Cohort IB) and Phase II (Cohort IIA and Cohort IIB) B-ALL with isolated EM disease
* Diagnosis of Burkitt's leukaemia/lymphoma or CML lymphoid in blast crisis
* History or presence of clinically relevant CNS pathology
* Presence of CNS-3 disease or CNS-2 disease with neurological changes
* Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management
* Active or latent Hepatitis B virus or active Hepatitis C virus
* Human Immunodeficiency Virus (HIV), HTLV-1, HTLV-2, syphilis positive test
* Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04404660
Study Brief:
Protocol Section:
NCT04404660