Status:
TERMINATED
Lmp1 and Lmp2 Specific CTLs Following Cd45 Antibody for Relapsed Ebv-Positive Hodgkin's Or Non-Hodgkin's Lymphoma
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Conditions:
Hodgkins Lymphoma
Non-Hodgkin Lymphoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The purpose of this study is to obtain blood (up to 90 ml or 18-teaspoonfuls on one or two occasions) to make LMP1- and LMP2-cytotoxic T-lymphocytes and grow them in the laboratory in such a way that ...
Detailed Description
Infusions of CD45 MAbs A fixed dose of CD45 MAbs will be used determined from our previous and ongoing studies in stem cell transplant recipients will be used 40, 400ug/kg over 6 to 8 hrs daily x 4 gi...
Eligibility Criteria
Inclusion
- Diagnosis of EBV-positive Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL; all histological subtypes except Burkitt's lymphoma), or EBV (associated)-T/NK-LPD, or chronic active EBV infection (CAEBV) after second or subsequent relapse including after autologous or syngeneic stem cell transplant (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated). CAEBV is defined as i) illness for greater than 3 months duration (EBV-related illness or symptoms including fever, persistent hepatitis, extensive lymphadenopathy, or hepatosplenomegaly); ii) increased amounts of EBV-DNA in peripheral blood (equal or greater than 400 genome copies per ug of DNA) or abnormal high levels of EBV antibodies (VCA IgG equal or greater than 1:5120 or EA IgG equal or greater than 1:640; and iii) no evidence of previous immunological abnormalities or other recent infection that might explain the observed condition.
- Patients with life expectancy greater than 6 weeks.
- Patients with a Karnofsky score (age ≥16) of greater than 50 or Lansky score (age\<16) of greater than 50
- No severe intercurrent infection.
- HIV negative donor (if autologous donor, patient must be HIV negative)
- Patient, parent/guardian able to give informed consent.
- Patients with bilirubin less than3 x normal, AST less than 5 x normal, and Hgb greater than 8.0
- Patients with a creatinine less than 2 x normal for age
- Patients should have been off other investigational therapy including T cell therapies for one month prior to entry in this study.
- Female patients with reproductive capacity must have a negative pregnancy test. Women of childbearing potential must not be pregnant and must be on effective birth control. 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 CAGT Protocol Review Committee and the FDA reviewer.
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 greater than 3x normal. AST greater than 5x normal and Hgb less than 8.0 g/dl
- Patients with a creatinine greater than 2x normal for age
- 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 :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00383097
Start Date
September 1 2006
End Date
February 1 2010
Last Update
May 24 2012
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