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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT02370160
Eligibility Criteria:
Inclusion Criteria:
* Histologic verification of B-cell lineage leukemia or B cell non-Hodgkin lymphoma and evidence of relapse/refractory disease with the presence of CD19 and/or CD22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node/tumor biopsy
* Relapsed refractory disease that has failed conventional therapy and other therapies of higher priority
* Karnofsky Performance status of ≥ 60% or, if less than 16 years of age, Lansky Play Score of ≥ 60 (appendix II)
* Recovered from effects of prior therapy
* Peripheral blast count under 50 x 10\^9/L
* Adequate organ function within 14 days (30 days for cardiac and pulmonary) of treatment start
* Women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study
* Voluntary written consent with appropriate parent/guardian consent and minor information sheet for participants \< 18 years of age
Exclusion Criteria:
* Presence of leukemic or infectious pulmonary parenchymal disease
* Presence of active CNS leukemia
* Presence of any uncontrolled systemic infection
* Documented uncontrolled seizure disorder- a seizure disorder controlled with medication
* Active neurologic disorder - peripheral neuropathy alone does not exclude a patient
* Active Hepatitis B or Hepatitis C (virus detectable by PCR)
* Documented penicillin or cephalosporin allergies
* Pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT02370160
Study Brief:
Protocol Section:
NCT02370160