Status:
COMPLETED
Most Closely HLA-Matched CTLs for Relapsed Epstein Barr Virus(EBV)-Associated Diseases
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Patients have a type of a lymph node cancer called lymphoma, a tumor of the nasal passages called nasopharyngeal carcinoma (NPC), a tumor of a particular type of muscle called leiomyosarcoma (LMS) or ...
Detailed Description
First, we will search our cell bank to see if there is a CTL line that is a match with the subject and his/her donor. This matching is done using HLA type, which measures 6 proteins on the cell surfac...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- SCREENING:
- 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
- Karnofsky/Lansky score 50% or more.
- Informed consent explained to and signed by patient or parent/guardian able to give informed consent and given a copy.
- TREATMENT:
- 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
- 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.
- Life expectancy 6 weeks or more.
- Tumor tissue is positive for EBV.
- Karnofsky/Lansky score 50% or more.
- 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.
- Pulse oximetry of greater than 90% on room air.
- If post allogeneic HSCT, patient must not have less than 50% donor chimerism in either peripheral blood or bone marrow.
- Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone at time of treatment.
- Informed consent explained to and signed by patient or parent/guardian able to give informed consent and given a copy.
- 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:
- Currently receiving any investigational agents or have received any tumor vaccines within previous 4 weeks.
- Active acute grade III-IV graft-versus-host disease.
- Severe intercurrent infection.
- Received alemtuzumab or other anti-T-cell antibody within 28 days.
- HIV seropositivity.
- Pregnancy (due to unknown effects of this therapy on a fetus) or lactation.
- Tumor in a location where enlargement could cause airway obstruction.
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01447056
Start Date
February 1 2012
End Date
January 22 2020
Last Update
February 7 2020
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030