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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.


Phase 1
N/A
N/A
Not Enrolling
Both
Hodgkin Disease, Non-Hodgkins Lymphoma

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Trial Information

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.


We will take 60-70 ml (12 teaspoonfuls) of blood from the subject. We will first make a B
cell line called a lymphoblastoid cell line or LCL by infecting the subjects blood with a
laboratory strain of EBV called B95. We will then use use this EBV infected cell line (which
have been treated with radiation so that they cannot grow) as stimulator cells and mix it
with more blood. This stimulation will train the T cells to kill EBV infected cells and
result in the growth of an EBV specific T cell line. We will then test the T cells to make
sure that they kill the EBV infected cells and not your normal cells and freeze them.

The cells will be thawed and injected into subjects over 10 minutes, after pretreatment with
Tylenol and Benadryl. A total of two doses will be given two weeks apart. All of the
treatments will be given at Texas Children's Hospital or The Methodist Hospital.

We will follow subjects in the clinic after the injections. At each visit about 10ml (2
teaspoonfuls) of blood will be taken every other week for 6 weeks after the injection and
then every 3 months for 1 year to monitor the subjects blood chemistry and hematology.

To learn more about the way the T cells are working in the subjects body, an extra 40mls (8
teaspoons) of blood will be taken pre-infusion, 3-4 days post infusion (optional) and at 1,
2, 4 and 6 weeks post-infusion and then at 3, 6, 9, and 12 months. The blood may be drawn
from the subjects central line at the time of their regular blood tests.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determine the safety of 2 IV injections of autologously derived EBV specific cytotoxic T-lymphocytes

Outcome Description:

The two injections will be given at day 0 and day 14. Three patients will be enrolled at the first dose level and followed for six weeks after the second dose (which will constitute a course) for evaluation of any critical toxicity.

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Principal Investigator

Catherine Bollard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

H-6422-ANGELA

NCT ID:

NCT00058773

Start Date:

January 1996

Completion Date:

August 2006

Related Keywords:

  • Hodgkin Disease
  • Non-Hodgkins Lymphoma
  • Hodgkin disease
  • non-Hodgkins Lymphoma
  • bone marrow transplant
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Texas Children's HospitalHouston, Texas  
The Methodist HospitalHouston, Texas  77030