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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT02588456
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent form must be obtained prior to any research procedure.
2. Relapsed or refractory B-cell ALL:
a. 1st or greater BM relapse OR b. Any marrow relapse after allogeneic HSCT and \> 100 days from transplant OR c. For patients with refractory disease: i. \< 60 years old that have not achieved a CR after \> 2 or more chemotherapy regimens ii. \>60 years old that have not achieved a CR after 1 prior chemotherapy regimen d. Patients with Ph+ ALL are eligible if they are intolerant to or have failed tyrosine kinase inhibitor therapy.
e. Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy.
3. Documentation of CD22 expression on malignant cells at relapse.
4. Adequate organ function defined as:
1. Creatinine \< 1.6 mg/dl
2. ALT/AST \< 3x upper limit of normal range
3. Direct bilirubin \<2.0 mg/dl
4. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea, pulse oxygen \> 92% on room air, and DLCO \> 40% (corrected for anemia)
5. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA
5. Evidence of disease by standard morphologic or by MRD criteria.
6. Male or female age ≥ 18 years.
7. ECOG Performance Status that is either 0 or 1.
8. No contraindications for leukapheresis.
9. Subjects of reproductive potential must agree to use acceptable birth control methods.
Exclusion Criteria:
1. Active hepatitis B or active hepatitis C.
2. HIV Infection.
3. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
4. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment.
5. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.
6. Concurrent use of systemic steroids or immunosuppressant medications. Recent or current use of inhaled steroids or physiologic replacement with hydrocortisone is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
7. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
8. Pregnant or nursing (lactating) women.
9. Receipt of a prior investigational study agent within 4 weeks prior to enrollment. \*Note- patients who have received anti-CD19 CART cells (e.g. CART19/CTL019) on an investigational study where cell infusion occurred greater than 4 weeks before the screening visit are NOT excluded.
10. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02588456
Study Brief:
Protocol Section:
NCT02588456