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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT03467256
Eligibility Criteria:
Inclusion Criteria:
* Ability to give informed consent (for patients \> 14 years old). For subjects \< 18 years old their legal guardian must give informed consent
* Patients with relapsed or refractory CD19-expressing B cell ALL :
* Induction failure, no CR after course 2 or MRD\>0,1% after 3 courses of high-risk protocol
* early bone marrow or combined relapse of acute lymphoblastic leukaemia, no CR or MRD\>0,1% after 1 course 2-nd line therapy
* ALL post ≥ 2nd relapse, no CR or MRD\>0,1% after 1 course 2-nd line therapy
* Relapse or MRD \>0,1% of ALL after stem cell transplant (\> 60 days post alloHSCT)
* Late bone marrow or combined relapse of acute lymphoblastic leukaemia, no CR or MRD\>0,1% after 2nd course of 2-nd line therapy
* There must be no available alternative curative therapies
* CD19 expression must be detected on greater than 30% by flow cytometry
* Patients must have measurable or evaluable disease at the time of enrolment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
* Patient Clinical Performance Status: Karnofsky \>50% or Lansky \>50%
* Patient Life Expectancy \> 8 weeks
* Patients recovered from acute toxic effects of all prior chemotherapy, immuno- or radiotherapy
* Patient absolute lymphocyte N \> or =100/mm3
* Patient cardiac function: left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO.
* Patients who agree to long-term follow up for up to 5 years (if received CD19 CAR-T cell infusion)
Exclusion Criteria:
1. \<30% expression of CD19 on the leukemic population
2. Active hepatitis B, C or HIV infection
3. Oxygen saturation \< or = 90%
4. Bilirubin \>3x upper norma limit
5. Creatinine \>3x upper norma limit
6. Active acute GVHD overall grade ≥2 (Seattle criteria)
7. Moderate/severe chronic GVHD (NIH consensus) requiring systemic steroids
8. Clinical signs of grade \>3 CNS disorders (seizure disorder, paresis, aphasia, cerebrovascular, ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
9. Pregnant or lactating women.
10. Active severe infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
25 Years
Study:
NCT03467256
Study Brief:
Protocol Section:
NCT03467256