Status:
TERMINATED
LMP2a-Specific Cytotoxic T-Lymphocytes, Lymphoma (ACDAL)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Lymphoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Patients have a type of cancer called Hodgkin's lymphoma or non-Hodgkin's lymphoma, which has come back or not gone away or is at high risk for coming back after treatment, including the best treatmen...
Detailed Description
Investigators first tested a biopsy of the tumor that has already been done to see if the tumor cells are EBV positive. They then got permission to take up to 60ml (12 teaspoonfuls) of blood from the ...
Eligibility Criteria
Inclusion
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin lymphoma, regardless of the histological subtype or EBV-associated T/NK cell Lymphoproliferative disease. This includes patients in second or subsequent relapse including post autologous or syngeneic stem cell transplant (or with active disease or in first relapse if immunosuppressive chemotherapy contraindicated or if the patient has relapsed multiple times and is currently in remission but has a high risk of relapse). (group A) OR Patients who have relapsed after allogeneic stem cell transplant for Hodgkin's Lymphoma or non-Hodgkin's Lymphoma (Group B)
- Life expectancy of greater than or equal to 6 weeks
- No severe intercurrent infection
- Patient, parent/guardian able to give informed consent
- Donor must be HIV negative (if autologous product used - patient must be HIV negative)
- Bilirubin less than or equal to 3x normal
- AST less than or equal to 5x normal
- Hgb higher than 8.0 g/L
- Creatinine less than or equal to 2x normal for age
- Patients should have been off other investigational therapy including T cells therapies for one month prior to entry in this study
- Karnofsky score of over or equal to 50
- No evidence of GVHD \>Grade II at time of enrollment
- Female patients with reproductive capacity must have a negative pregnancy test
Exclusion
- Patient, parent/guardian unable or unwilling to give informed consent
- Pregnant women
- Patients with a Karnofsky score of \< 50
- Patients with a severe intercurrent infection
- Patients with a life expectancy of \<6 weeks
- Patients with a bilirubin of more than 3x normal. AST of more than 5x normal
- Patients with a creatinine of more than 2x normal for age
- GVHD greater than Grade II at time of enrollment
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00082225
Start Date
October 1 2003
End Date
January 1 2008
Last Update
February 7 2017
Active Locations (2)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030
2
The Methodist Hospital
Houston, Texas, United States, 77030