3rd Party LMP1/2-Specific Cytotoxic T Lymphocytes for EBV-Associated Lymphoma
|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.
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 National Research Institute|