Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Autologous or Donor Cytotoxic T-Lymphocytes in Treating Patients With Relapsed Epstein-Barr Virus-Associated Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	Any age	NCI	BCM-H-9936 NCT00070226

Objectives

1. Determine the safety of autologous or allogeneic LMP2A-specific cytotoxic T-lymphocytes in patients with relapsed Epstein-Barr virus-positive Hodgkin's or non-Hodgkin's lymphoma.
2. Determine the survival and immune function of patients treated with this regimen.
3. Determine the antiviral and antitumor effects of this regimen in these patients.
4. Obtain preliminary information on the safety of and response to an extended dosage of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of Epstein-Barr virus-positive Hodgkin's or non-Hodgkin's lymphoma
  • Any histological subtype
  • Meets criteria for 1 of the following:
    • Second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy is contraindicated (e.g., patients who develop Hodgkin's lymphoma after a prior solid organ transplant, who have lymphoma as a second malignancy, or who have relapsed multiple times AND at high risk of relapse) (group A)
    • In remission OR with minimal residual disease after autologous stem cell transplantation for Hodgkin's or non-Hodgkin's lymphoma or lymphoepithelioma (group B)
    • In remission OR with detectable disease after allogeneic stem cell transplantation (group C)

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 1 month since prior investigational therapy

Patient Characteristics:

Age

• Any age

Performance status

• Karnofsky 50-100%

Life expectancy

• At least 6 weeks

Hematopoietic

• Hemoglobin greater than 8.0 g/dL
• More than 50% donor chimerism in either peripheral blood or bone marrow after allogeneic stem cell transplantation
• No evidence of graft-vs-host disease > grade II

Hepatic

• Bilirubin less than 3 times normal
• AST less than 5 times normal

Renal

• Creatinine less than 2 times normal

Other

• Not pregnant
• Fertile patients must use effective contraception
• No concurrent severe infection
• HIV negative

Expected Enrollment

A total of 18 patients will be accrued for this study.

Outcomes

Safety at 6 weeks

Disease response at 8 weeks

Outline

Peripheral blood is collected from the patient or a donor and allogeneic or autologous dendritic cells (DC) are generated over 7 days using sargramostim (GM-CSF) and interleukin-4 (IL-4). DC are transduced with recombinant AdLMP2A and matured with GM-CSF, TNFa, PGE-1, and IL-4 over 2 days to stimulate cytotoxic T-lymphocytes (CTL). Patients receive LMP2A-specific CTL IV over 1-10 minutes on days 0 and 14.

Cohorts of 3-6 patients receive escalating doses of LMP2A-specific CTL.

Patients are evaluated at 8 weeks. Patients with stable disease or a partial response may receive 6 additional doses of LMP2A-specific CTL IV over 1-10 minutes once monthly.

Bollard CM, Gottschalk S, Leen AM, et al.: Complete responses of relapsed lymphoma following genetic modification of tumor-antigen presenting cells and T-lymphocyte transfer. Blood 110 (8): 2838-45, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Dan L. Duncan Cancer Center at Baylor College of Medicine

Helen Heslop, MD, Protocol chair		Ph: 832-824-4662 Email: hheslop@bcm.tmc.edu

Registry Information
Official Title		Administration of LMP2A-Specific Cytotoxic T Cells to Patients with Relapsed EBV Positive Lymphoma
Trial Start Date		2003-07-01
Trial Completion Date		2009-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00070226
Date Submitted to PDQ		2003-08-15
Information Last Verified		2008-03-30
NCI Grant/Contract Number		CA94237

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