Giving Gene Marked EBV Specific T-Cells to Patients Receiving a BMT for Relapsed EBV-Positive Hodgkin Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 November 2012
• Main ID: NCT00058773
• Date of registration: 11/04/2003
• Primary sponsor: Baylor College of Medicine
• Public title: Giving Gene Marked EBV Specific T-Cells to Patients Receiving a BMT for Relapsed EBV-Positive Hodgkin Disease ANGELA
• Scientific title: Administration of Autologous Neomycin Resistant Gene Marked EBV Specific Cytotoxic T-Lymphocytes as Therapy for Patients Receiving Autologous Bone Marrow Transplant for Relapsed EBV-Positive Lymphoma.
• Date of first enrolment: January 1996
• Target sample size: 5
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00058773
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Catherine Bollard, MD
• Affiliation: Baylor College of Medicine

Key inclusion & exclusion criteria

INCLUSION CRITERIA:

- Any patient with Hodgkin disease or non-Hodgkin Lymphoma, containing the EBV genome
or antigen, receiving an autologous bone marrow transplant regardless of age or sex.

- Patients with tumor tissue EBV +ve.

- Patients with life expectancy >6 weeks.

- Patients with Karnofsky score of > 50.

- No severe intercurrent infection.

- Patient, parent/guardian able to give informed consent.

- Patient with Bilirubin <2x normal, SGOT <3x normal, and ANC greater than 500mm

- Patients with creatinine <2x normal for age or creatinine clearance >2x normal for
age.

- Patients should have been off other investigational therapy for one month prior to
entry in this study.

EXCLUSION CRITERIA:

- Patients with a life expectancy of <6 weeks.

- Patients with an EBV positive Lymphoma secondary to an acquired or congenital
immunodeficiency.

- Patients with a Karnofsky score less than or equal to 50.

- Patients with a severe intercurrent infection.

- Patients with a bilirubin >2x normal,SGOT >3x normal, or abnormal prothrombin time.

- Patients with a creatinine >2x normal for age or creatinine clearance <2x normal for
age.

- Patients with an ANC <500mm

- Patient, parent/guardian unable to give informed consent.

- Patients who have been on other investigational therapy within one month prior to
entry in this study.

- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from
this research. Women of childbearing potential must be on appropriate birth control
for the duration of the study and 6 months after completion of the study. In
addition, the male partner should use a condom.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hodgkin Disease

Non-Hodgkins Lymphoma

Intervention(s)

Drug: Infusion of EBV Specific Cytotoxic T-Lymphocytes

Primary Outcome(s)

determine the safety of 2 IV injections of autologously derived EBV specific cytotoxic T-lymphocytes [Time Frame: 8 weeks]

Secondary Outcome(s)

determine the survival, immunological efficacy and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines. [Time Frame: 1 year]

Secondary ID(s)

ANGELA

H-6422-ANGELA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Center for Cell and Gene Therapy, Baylor College of Medicine

Texas Children's Hospital

The Methodist Hospital System