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 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT00709033
Eligibility Criteria:
INCLUSION CRITERIA:
FOR TREATMENT:
* Recurrent low or intermediate grade B-cell lymphoma or B-CLL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory intermediate B cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation.
* CD19-positive tumor
* EBV seropositivity (in patient and donor, as applicable)
* Recovered from the acute toxic effects of all prior chemotherapy at least a week before entering this study.
* Not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six weeks.
* No treatment with rituximab within the previous 8 weeks.
* ANC \> 500, Hgb \> 8.0\*
* Bilirubin less than 3 times the upper limit of normal\*
* AST less than 5 times the upper limit of normal\*
* Serum creatinine less than 3 times upper limit of normal\*
* Pulse oximetry of \> 90% on room air\*
* Adequate pulmonary function with FEV1, FVC and DLCO \>35%\* of expected corrected for hemoglobin
* Karnofsky or Lansky score of \> 60%.
* Available autologous or syngeneic transduced EBV-specific cytotoxic T lymphocytes and peripheral blood T-cells with 15% or greater expression of CD19CAR determined by flow-cytometry.
* Patients or legal guardians must understand and sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
* Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.
EXCLUSION CRITERIA:
* History of hypersensitivity reactions to murine protein-containing products.
* Pregnant or lactating.
* Tumor in a location where enlargement could cause airway obstruction.
* Active infection with HIV, HBV, HCV or CMV.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00709033
Study Brief:
Protocol Section:
NCT00709033