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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT00968760
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a history of CD19+ lymphoid malignancies that are beyond first remission or primary refractory to treatment.
2. Age 18 to 75 years.
3. Zubrod performance 0-1 or Karnofsky greater than or equal to 80%.
4. Patient able to provide written informed consent.
5. Patient able to provide written informed consent for the long-term follow-up gene therapy study.
6. Eligibility at time of transplant conditioning regimen (criteria 6-13): Zubrod performance 0-1 or Karnofsky greater than or equal to 80%.
7. Left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
8. No symptomatic pulmonary disease. FEV1, FVC and DLCO \>/= 50% of expected, corrected for hemoglobin.
9. Serum creatinine \</= 1.8mg/dL or creatinine clearance \>/= 40 cc/min.
10. Adequate hepatic function, as defined by SGPT \<3 X upper limit of normal; serum bilirubin and alkaline phosphatase \<2 X upper limit of normal, or considered not clinically significant.
11. If positive Hepatitis B and/or Hepatitis C serology, discuss with Principal Investigator or designee and consider liver biopsy.
12. No pleural/pericardial effusion or ascites estimated to be \>1L.
13. Not breast feeding or pregnant. Pregnancy determined by a positive beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
14. Eligibility at time of T-cell infusion (criteria 14-15): No systemic corticosteroids within 3 days prior to T-cell infusion.
15. Not experiencing any new Grade \>2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to T-cell infusion.
16. Eligibility criteria for administration of IL-2 after T-cell infusion: Absence of new adverse event of grade \>2 (CTC vs. 4) involving cardiopulmonary, hepatic (excluding albumin), gastrointestinal, neurologic, or renal toxicity probably or definitely attributed to infused T cells within one week of cells.
Exclusion Criteria:
1. Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
2. Patients with known allergy to bovine or murine products.
3. Positive serology for HIV.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00968760
Study Brief:
Protocol Section:
NCT00968760