3rd Party LMP1/2-Specific Cytotoxic T Lymphocytes for EBV-Associated Lymphoma
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|ClinicalTrials.gov Identifier: NCT02057445|
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : December 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkins Lymphoma Hodgkins Lymphoma Lymphoproliferative Disorder||Drug: EBV CTL's Other: Peripheral Blood Donor||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Pilot Study of Third Party LMP1/2-Specific Cytotoxic T Lymphocytes for Treatment of Patients With Refractory /Relapsed EBV-Associated Lymphoma A Childhood, Adolescent and Young Adult Lymphoma Cell Therapy Consortium (LCTC) Multicenter Clinical Trial|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2017|
EBV+ patients will receive 3rd party LMP-CTLs for treatment of EBV infection and/or disease
Drug: EBV CTL's
Eligible patients with a matched cell line will be infused with 3rd party CTLs and monitored for adverse events and response. Patients who show a response and tolerate the infusion well may receive up to 5 infusions total 4-6 weeks apart.
Healthy donors who are EBV+ will be asked to donate 60-120 ml of peripheral blood for development of cell lines to be stored for cell line bank.
Other: Peripheral Blood Donor
Donors who are EBV+ and meet the eligibility criteria will be consented to provide 60-120 ml peripheral blood once for future use for this and other clinical trials using 3rd party CTLs.
- To determine the safety of giving 3rd party EBV-CTLs [ Time Frame: 1 year ]Patients will be monitored for any unexpected adverse events related to investigational product.
- To develop a third party bank of LMP-specific CTL [ Time Frame: on going ]EBV positive donors will be asked to provide an extra sample of peripheral blood to build a donor bank of EBV-CTLs for this protocol and future use.
- To measure the response rate [ Time Frame: 1 year ]patients will be followed a year following administration of cells for disease response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057445
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States|
|United States, New York|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|Principal Investigator:||Mitchell Cairo, MD||New York Medical College|
|Principal Investigator:||Catherine Bollard, MD||Children's Research Institute|