Epstein Barr Virus (EBV) Specific Cytotoxic T-Cells, Relapsed Lymphoma, ANGEL

Completed · Phase 1

Conditions studied: Epstein-Barr Virus-Related Hodgkin Lymphoma, Epstein-Barr Virus-Related Non-Hodgkin Lymphoma, EBV Positive Plasma Cell Neoplasm

In brief

Patients have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma which has come back or not gone away after treatment, including the best treatment known for relapsed Lymphoma. Patients are being asked to volunteer to be in a research study using Epstein Barr virus specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has never been used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been used successfully in children with other types of blood cancer caused by EBV after bone marrow transplantation. Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus before or at the time of their diagnosis of the Lymphoma. EBV is often found in the cancer cells suggesting that it may play a role in causing Lymphoma. The cancer cells infected by EBV are very clever because they are able to hide from the body's immune system and escape destruction. Investigators want to see if it's possible to grow special white blood cells, called T cells, that have been trained to kill EBV infected cells. Purpose The purpose of this study is to find the largest safe dose of EBV specific cytotoxic T cells, to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease and non-Hodgkin Lymphoma.

Key facts

Study ID

NCT00058617

Run by

Baylor College of Medicine

People needed

13

Starts

1996-01-01

Expected to finish

2014-07-01

Last updated by the study team

2017-02-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient with EBV positive Hodgkin disease or non-Hodgkin Lymphoma, or plasma cell neoplasms in second relapse regardless of age or sex, in first relapse or with primary disease or in first remission if immunosuppressive chemotherapy contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richters transformation of CLL.
• Life expectancy of greater than 6 weeks.
• No severe intercurrent infection
• Patient, parent/guardian able to give informed consent
• Bilirubin <2x normal,
• SGOT <3x normal,
• Hgb greater than 8.0 g/L
• Creatinine <2x normal for age
• Must have been off other investigational therapy for one month prior to entry in this study.
• Karnofsky score of greater than or equal to 50.

You may not qualify if…

• Patient with an EBV positive NHL secondary to an acquired immunodeficiency.
• Patients who are HIV positive
• Patient, parent/guardian unable to give informed consent
• Patients with a Karnofsky score of < 50.
• Patients with a life expectancy of <6 weeks
• Patients with a bilirubin greater than 2x normal. SGOT greater than 3x normal
• Patients with a creatinine greater than 2x normal for age
• Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.
• Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer.

Where it is running

• Houston Methodist Hospital — Houston, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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