Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies
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|ClinicalTrials.gov Identifier: NCT00002663|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|EBV-induced Lymphomas EBV-associated Malignancies Transplant Patients With EBV Viremia at High Risk of Developing a Recurrent EBV Lymphoma||Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes||Phase 1 Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Evaluation of the Toxicity and Therapeutic Effects of Epstein-Barr Virus-Immune T-Lymphocytes Derived From a Normal HLA-Compatible or Haplotype-Matched Donor in the Treatment of EBV-Associated Lymphoproliferative Diseases or Malignancies and Patients With Detectable Circulating Levels of EBV DNA Who Are at High Risk for EBV-Associated Lymphoproliferative Diseases|
|Actual Study Start Date :||March 1995|
|Actual Primary Completion Date :||July 2019|
|Actual Study Completion Date :||July 2019|
Experimental: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Patients receive adoptive immunotherapy with allogeneic Epstein Barr virus (EBV)-specific cytotoxic T lymphocytes IV on days 1, 8, and 15. After the third dose, patients will be observed for 3 weeks. After the 3 week observation period, additional courses of treatment may be given in the absence of disease progression or unacceptable toxicity.
Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
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): NCT00002663
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Study Director:||Minoti Hiremath, MD||Atara Biotherapeutics|