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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT01447056
Eligibility Criteria:
INCLUSION CRITERIA:
SCREENING:
1. Any patient, regardless of age or sex, with one or more of the following EBV-positive or associated disorders, regardless of the histological subtype: - Hodgkin lymphoma - Non-Hodgkin lymphoma - Lymphoproliferative disorder - Nasopharyngeal carcinoma - Leiomyosarcoma - Severe chronic active EBV infection syndrome (SCAEBV), defined as high EBV viral load in plasma or PBMC (\> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
2. Karnofsky/Lansky score 50% or more.
3. Informed consent explained to and signed by patient or parent/guardian able to give informed consent and given a copy.
TREATMENT:
1. Any patient, regardless of age or sex, with one or more of the following EBV-positive or associated disorders, regardless of the histological subtype: - Hodgkin lymphoma - Non-Hodgkin lymphoma - Lymphoproliferative disorder - Nasopharyngeal carcinoma - Leiomyosarcoma - Severe chronic active EBV infection syndrome (SCAEBV), defined as high EBV viral load in plasma or PBMC (\> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
2. The disease needs to be in one of the following stages: - At diagnosis or in first relapse AND the patient is unable to receive conventional chemotherapy for his/her condition. - In second or subsequent relapse. - With residual disease after autologous, syngeneic or allogeneic HSCT.
3. Life expectancy 6 weeks or more.
4. Tumor tissue is positive for EBV.
5. Karnofsky/Lansky score 50% or more.
6. Bilirubin less than 3 times higher than the normal limits, AST less than 5 times higher than the normal limits, Hgb greater than 8.0 g/dL and serum creatinine less than 3 times higher than the normal limits.
7. Pulse oximetry of greater than 90% on room air.
8. If post allogeneic HSCT, patient must not have less than 50% donor chimerism in either peripheral blood or bone marrow.
9. Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone at time of treatment.
10. Informed consent explained to and signed by patient or parent/guardian able to give informed consent and given a copy.
11. 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:
SCREENING:
1\. Known HIV positivity.
TREATMENT:
1. Currently receiving any investigational agents or have received any tumor vaccines within previous 4 weeks.
2. Active acute grade III-IV graft-versus-host disease.
3. Severe intercurrent infection.
4. Received alemtuzumab or other anti-T-cell antibody within 28 days.
5. HIV seropositivity.
6. Pregnancy (due to unknown effects of this therapy on a fetus) or lactation.
7. Tumor in a location where enlargement could cause airway obstruction.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01447056
Study Brief:
Protocol Section:
NCT01447056