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 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT00182650
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed follicular non-Hodgkin's lymphoma (NHL)
* High-risk disease, as defined by any of the following:
* Relapsed within 6 months after the last treatment
* Failed to achieve a complete response during the last treatment
* Relapsed after prior autologous hematopoietic stem cell transplantation (HSCT)
* No current transformation of lymphoma (e.g., elements of intermediate- or high-grade lymphoma by biopsy)
* No active CNS disease by lumbar puncture or radiology scan NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
* 16 to 70
Performance status
* Karnofsky 50-100%
Life expectancy
* More than 16 weeks
Hematopoietic
* Absolute neutrophil count \> 500/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\* (unless due to Gilbert's disease)
* ALT ≤ 2.5 times ULN\* NOTE: \*Unless due to NHL
Renal
* Creatinine ≤ 1.5 times ULN\* OR
* Creatinine clearance ≥ 80 mL/min\* NOTE: \*Unless due to NHL
Immunologic
* HIV negative
* Epstein-Barr virus positive
* No history of allergy or intolerance to ganciclovir
Other
* Negative pregnancy test
* No history of another malignancy except basal cell skin cancer or carcinoma in situ
* No other uncontrolled or severe illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior allogeneic HSCT
* No other immunotherapy during and for approximately 65 days after the last T-cell infusion, unless approved by the Principal Investigator (PI)
Chemotherapy
* No other chemotherapy during and for approximately 65 days after the last T-cell infusion, unless approved by the PI
* Patients may receive chemotherapy after leukapheresis while waiting for CD19-specific T cells to be manufactured
Endocrine therapy
* No systemic corticosteroids during and for approximately 65 days after the last T-cell infusion, unless approved by the PI
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No concurrent participation in another investigational study
* No immunosuppression agents or other investigational agents during and for approximately 65 days after the last T-cell infusion, unless approved by the PI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
70 Years
Study:
NCT00182650
Study Brief:
Protocol Section:
NCT00182650