Therapeutic Effects of Epstein-Barr Virus Immune T-Lymphocytes Derived From a Normal HLA-Compatible Or Partially-Matched Third-Party Donor in the Treatment of EBV Lymphoproliferative Disorders and EBV-Associated Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01498484|
Recruitment Status : Active, not recruiting
First Posted : December 23, 2011
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|EBV-induced Lymphomas EBV-associated Malignancies Transplant Patients With EBV Viremia at High Risk for Developing a Recurrent EBV Lymphoma||Biological: EBV-specific T cells||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Therapeutic Effects Of Epstein-Barr Virus Immune T-Lymphocytes Derived From a Normal HLA-Compatible Or Partially-Matched Third-Party Donor in the Treatment of EBV Lymphoproliferative Disorders and EBV-Associated Malignancies|
|Actual Study Start Date :||December 2011|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: EBV-specific T cells
Patients will each receive a course of three weekly infusions of EBV-specific T cells (EBV-CTLs). Each weekly dose will provide 2 x 10^6 T cells/kg recipient weight (+/- 3 days). After the third dose, patients will be observed for approximately 3 weeks.
Biological: EBV-specific T cells
EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated lymphomas and lymphoproliferative disorders.
- Efficacy as defined by response rate [ Time Frame: 1 year ]
- In vivo expansion and duration of EBV-CTLs measured via CTLp assay over time (cells/mL/time) [ Time Frame: 1 year ]
- Durability of clinical responses (time) [ Time Frame: 1 year ]
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): NCT01498484
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Susan Prockop, MD||Memorial Sloan Kettering Cancer Center|