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



Status:Recruiting
Conditions:Cancer, Blood Cancer, Infectious Disease, Lymphoma, Hematology, Leukemia
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:Any
Updated:8/16/2018
Start Date:March 1995
End Date:August 2019
Contact:Susan Prockop, MD
Phone:212-639-6715

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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.


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.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Susan Prockop, MD
Phone: 212-639-6715
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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