Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Atara Biotherapeutics
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Atara Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00002663
First received: November 1, 1999
Last updated: December 22, 2016
Last verified: December 2016

November 1, 1999
December 22, 2016
March 1995
March 2017   (final data collection date for primary outcome measure)
  • Efficacy as defined by response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • In vivo expansion and duration of EBV-CTLs measured via CTLp assay over time (cells/mL/time) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Durability of clinical responses (time) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002663 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies
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
The purpose of this phase I/II trial is to study the side effects and best dose of biological therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
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.
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.
Intervention: Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
December 2017
March 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologically documented EBV antigen positive lymphoproliferative disease, lymphoma, or other EBV-associated malignancy OR
  • Severely immunocompromised patients who develop blood levels of EBV DNA exceeding 500 copies/ml DNA, and are therefore at high risk for developing an EBV LPD

It is expected that five types of patients afflicted with EBV-associated lymphomas or lymphoproliferative diseases will be referred and will consent to participate in this trial. These are:

  1. Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic marrow transplant.
  2. Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders following an allogeneic organ transplant.
  3. Patients with AIDS developing EBV lymphomas or lymphoproliferative diseases as a consequence of the profound acquired immunodeficiency induced by HIV.
  4. Patients who develop EBV lymphomas or lymphoproliferative diseases as a consequence of profound immunodeficiencies associated with a congenital immune deficit or acquired as a sequela of anti-neoplastic or immunosuppressive therapy.
  5. Patients who develop other EBV-associated malignancies without pre-existing immune deficiency, including: EBV+ Hodgkin's and Non- Hodgkin's disease, EBV+ nasopharyngeal carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma.

Exclusion Criteria:

The following patients will be excluded from this study:

  • Moribund patients who, by virtue of heart, kidney, liver, lung, or neurologic dysfunction not related to lymphoma, are unlikely to survive the 6-8 weeks required for in vitro generation and expansion of the EBV-specific T cells to be used for therapy and the subsequent 3 weeks required to achieve an initial assessment of the effects of infusions of EBV-specific T cells.
  • Pregnancy does not constitute a contraindication to infusions of EBV-specific T cells.
All
Child, Adult, Senior
No
Contact: Susan Prockop, MD 212-639-6715
Contact: Esperanza Papadopoulos, MD 212-639-8276
United States
 
NCT00002663
95-024, P30CA008748, MSKCC-95024, NCI-V95-0685
Not Provided
Not Provided
Not Provided
Atara Biotherapeutics
Atara Biotherapeutics
  • Memorial Sloan Kettering Cancer Center
  • National Cancer Institute (NCI)
Principal Investigator: Susan Prockop, MD Memorial Sloan Kettering Cancer Center
Atara Biotherapeutics
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP