T Lymphocytes in Treating Patients With Lymphoproliferative Disorder After Undergoing Organ Transplant - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00607698

Purpose

RATIONALE: T lymphocytes that have been treated with the Epstein-Barr virus may help the body build an effective immune response to kill abnormal cells.

PURPOSE: This clinical trial is studying the best dose of T lymphocytes in treating patients with lymphoproliferative disorder after undergoing organ transplant.

Condition	Intervention
Lymphoproliferative Disorder	Biological: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes

Study Type:	Interventional
Study Design:	Treatment
Official Title:	AUTOLOGOUS EBV SPECIFIC CTLS FOR PROPHYLAXIS AND THERAPY OF EBV LYMPHOMA POST SOLID ORGAN TRANSPLANT

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Dose of Epstein-Barr virus-specific cytotoxic T-cell lymphocytes that produces the desired biological activity [ Designated as safety issue: No ]

Secondary Outcome Measures:

Antiviral and immunological efficacy [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	March 2001
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To determine a dose of Epstein-Barr virus (EBV)-specific cytotoxic T-cell lymphocytes (CTLs) that produces the desired biological activity in patients with post-transplant lymphoproliferative disorder.

Secondary

To evaluate the antiviral and immunological efficacy of intravenous injections of EBV-specific CTLs in these patients.

OUTLINE: This is a multicenter study.

Patients receive autologous Epstein-Barr virus-specific cytotoxic T-cell lymphocytes IV on day 1. Patients may receive additional vaccinations every 6 weeks in the presence of no response or relapsed disease and in the absence of unacceptable toxicity.

After completion of study therapy, patients are followed monthly for 3 months and then every 3 months for 1 year.

Eligibility

Ages Eligible for Study:	up to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Meeting one of the following criteria:
- Organ transplant recipients at high risk of developing lymphoproliferative disease (LPD):
  - Epstein-Barr virus (EBV)-seronegative at time of transplant and develop a positive EBV DNA PCR
  - Organ transplant recipients receiving muromonab-CD3 for immunosuppression
- Organ transplant recipients with evidence or history of LPD (i.e., EBV-related LPD either at diagnosis or post rituximab, chemotherapy, or other treatment)
- Organ transplant recipients with EBV DNA level in peripheral blood mononuclear cells > 1,000 EBV genome copies (even without evidence of EBV LPD) in 2 consecutive determinations
- LPD responding to conventional treatment but with evidence of graft rejection
- EBV reactivation (fevers or lymphadenopathy)

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 6 weeks
Creatinine < 3 times normal
Bilirubin < 5 times normal
AST < 5 times normal
No severe intercurrent infection

PRIOR CONCURRENT THERAPY:

No other investigational cellular therapies within the past 30 days
No concurrent supplemental oxygen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607698

Locations

United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Houston, Texas, United States, 77030-2399

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:

Helen E. Heslop, MD

Baylor College of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000582810, BCM-H-9454, BCM-EUCLID
Study First Received:	February 1, 2008
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00607698 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

post-transplant lymphoproliferative disorder

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Immunoproliferative Disorders
Pathologic Processes

Disease
Immune System Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 03, 2009