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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT00062868
Eligibility Criteria:
ALASCER (Part 1 of Study)
INCLUSION CRITERIA
1. Any patient, regardless of age or sex, with EBV-positive Lymphoma, or lymphoepithelioma regardless of the histological subtype or EBV (associated)-T/NK-LPD.
In second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiply relapsed patients in remission who have a high risk of relapse) OR any patient with primary disease or in first remission if immunosuppressive chemotherapy is contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richters transformation of CLL. (Group A) OR In remission or with minimal residual disease status after autologous or syngeneic SCT for Hodgkin's or non-Hodgkin's Lymphoma or lymphoepithelioma. (Group B) OR In remission or with detectable disease after allogeneic SCT. (Group C)
2. Patients with life expectancy \> 6 weeks.
3. Patients with a Karnofsky/Lansky score of \> 50
4. No severe intercurrent infection.
5. Donor HIV negative (if autologous product - patient must be HIV negative)
6. No evidence of GVHD \> Grade II at time of enrollment.
7. If post allogeneic SCT must not have less than 50% donor chimerism in either peripheral blood or bone marrow
8. Patient, parent/guardian able to give informed consent.
9. Patients with bilirubin \<3x normal, AST \<5x normal, and Hgb \>8.0 (see Section 7.2).
10. Patients with a creatinine \<2x normal for age
11. Patients should have been off other investigational therapy for one month prior to entry in this study.
EXCLUSION CRITERIA
1. Patients with a life expectancy of \<6 weeks.
2. Patients with a Karnofsky/Lansky score of \< 50.
3. Patients with a severe intercurrent infection.
4. Patients with bilirubin \>3x normal. AST \>5x normal or abnormal prothrombin time.
5. Patients with a creatinine \>2x normal for age
6. Donors who are HIV positive (Patients who are HIV positive - if autologous product)
7. Patients with GVHD Grades III-IV
8. Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.
Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer.
ALCI and ALCI Expansion (Part 2 of Study)
INCLUSION CRITERIA:
1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, or lymphoepithelioma or leiomyosarcoma regardless of the histological subtype or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic EBV#
(#SCAEBV is defined as patients with high EBV viral load in plasma or PBMC (\>4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV)
a - In second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiply relapsed patients currently in remission who have a high risk of relapse) OR with primary disease or in first or subsequent remission if immunosuppressive chemotherapy is contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richters transformation of CLL.(Group A)
OR
b - In remission or with minimal residual disease status after autologous or syngeneic SCT for Hodgkin's or non-Hodgkin's Lymphoma/Lymphoepithelioma/SCAEBV. (Group B)
OR
c - Patients in remission or with detectable disease after allogeneic SCT. (Group C)
2. Patients with life expectancy 6 weeks or greater.
3. Tumor tissue EBV positive
4. Patients with a Karnofsky/Lansky score of 50 or greater
5. Donor HIV negative (if autologous product - patient must be HIV negative)
6. If post allogeneic SCT must not have less than 50% donor chimerism in either peripheral blood or bone marrow
7. Patients with bilirubin 3x normal or less, AST 5x normal or less, and Hgb greater than 8.0
8. Patients with a creatinine 2x normal or less for age
9. Patients should have been off other investigational therapy for one month prior to entry in this study.
10. Patient, parent/guardian able to give informed consent.
EXCLUSION CRITERIA:
1. Patients with a severe intercurrent infection.
2. Donors who are HIV positive or Patients who are HIV positive if autologous product to be used
3. Patients with greater than Grade II GVHD
4. Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00062868
Study Brief:
Protocol Section:
NCT00062868