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:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-26 @ 3:59 PM
NCT ID:
NCT02412306
Eligibility Criteria:
Adult Subjects Key Inclusion Criteria:
* Age ≥ 18 years old at enrollment
* Subjects with Philadelphia-negative B-precursor ALL, with any of the following:
* Relapsed or refractory after first line therapy with first remission duration ≤ 12 months; or
* Relapsed or refractory after first salvage therapy; or
* Relapsed or refractory within 12 months of allogeneic hematopoietic stem cell transplant (alloHSCT)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
* Greater than 5% blasts in bone marrow
Pediatric Subjects Key Inclusion Criteria:
* Age \< 18 years old at enrollment
* Relapsed/refractory disease, defined as one of the following:
* second or later bone marrow relapse;
* any marrow relapse after alloHSCT; or
* Refractory to other treatments:
* For subjects in first relapse: failure to achieve a complete response (CR) following a full standard reinduction chemotherapy regimen
* For subjects who have not achieved a first remission: failure to achieve remission following a full standard induction regimen
* Greater than 5% blasts in bone marrow
* Karnofsky performance status ≥ 50% for subjects ≥ 16 years
* Lansky performance status ≥ 50% for subjects \< 16 years
Key Exclusion Criteria
* Subjects with Burkitt´s Leukemia according to World Health Organization (WHO) classification
* History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis; with the exception of well-controlled CNS leukemia
* Active ALL in the CNS or testes
* Current autoimmune disease or history of autoimmune disease with potential CNS involvement
* Autologous HSCT within 6 weeks prior to start of blinatumomab treatment
* AlloHSCT within 12 weeks prior to start of blinatumomab treatment
* Any active acute Graft-versus-Host Disease (GvHD) grade 2-4 according to Glucksberg criteria or active chronic GvHD requiring systemic treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Study:
NCT02412306
Study Brief:
Protocol Section:
NCT02412306