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T Lymphocytes in Treating Patients Undergoing a Donor Bone Marrow Transplant

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsored by: Baylor College of Medicine
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00608309
  Purpose

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

PURPOSE: This phase I trial is studying the side effects and best way to give T lymphocytes in treating patients undergoing a donor bone marrow transplant.


Condition Intervention Phase
Cancer
Drug: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
Procedure: adjuvant therapy
Procedure: immunological diagnostic method
Procedure: polymerase chain reaction
Phase I

Genetics Home Reference related topics:   ataxia-telangiectasia    breast cancer    Friedreich ataxia   

MedlinePlus related topics:   Bone Marrow Transplantation    Breast Cancer    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Multiple Myeloma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Administration of EBV Specific Cytotoxic T Lymphocytes to Recipients of Mismatched-Related or Phenotypically Similar Unrelated Donor Marrow Grafts

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

Primary Outcome Measures:
  • Generation of Epstein-Barr virus-specific cytotoxic T-cell lines from bone marrow transplantation (BMT) donors [ Designated as safety issue: No ]
  • Safety of one intravenous injection of BMT donor-derived EBV-specific cytotoxic T lymphocytes (CTLs) in BMT recipients at high risk [ Designated as safety issue: Yes ]
  • Comparison of the antiviral and immunological efficacy of a single dose of CTLs vs the multiple dose regimens previously employed [ Designated as safety issue: Yes ]

Estimated Enrollment:   20
Study Start Date:   May 1993
Estimated Primary Completion Date:   December 2022 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • To generate Epstein-Barr virus (EBV)-specific cytotoxic T-cell lines from bone marrow transplantation (BMT) donors.
  • To determine the safety of one intravenous injection of BMT donor-derived EBV-specific cytotoxic T lymphocytes (CTLs) in BMT recipients at high risk.
  • To compare the antiviral and immunological efficacy of a single dose of CTLs versus the multiple dose regimens previously employed.

OUTLINE: Patients receive an infusion of Epstein-Barr Virus (EBV)-specific T cells on or after day 45 of an allogeneic stem cell transplantation regimen. EBV DNA persistence in peripheral blood is monitored by polymerase chain reaction before and after the infusion. Patients with EBV DNA levels above 1000 copies/μg or with persistent disease may receive up to 5 additional infusions of cytotoxic T lymphocytes (CTLs). Treatment repeats every 6 weeks in the absence of unacceptable toxicity.

Patients undergo blood sample collection periodically for immunophenotyping and tetramer analysis, assessment of EBV DNA content, and for reactivation of EBV-specific CTL lines to analyze specificity.

After completion of study treatment, patients are followed weekly for 6 weeks and then every 3 months for up to 1 year.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Receiving a T-cell depleted bone marrow transplantation from a mismatched family member or unrelated donor
    • Receiving a matched sibling transplantation or T-replete transplantation AND meets the following criteria:

      • At high risk of developing Epstein-Barr virus lymphoproliferative disease (EBV LPD) due to 1 of the following conditions:

        • Underlying disease (e.g., Wiskott-Aldrich syndrome or ataxia telangiectasia)
        • Past history of EBV LPD or other EBV-associated malignancy

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 6 weeks
  • No graft-versus-host disease ≥ grade 2
  • No severe renal disease (i.e., creatinine clearance < half normal for age)*
  • No severe hepatic disease (i.e., bilirubin > 2 times normal OR SGOT > 3 times normal)*
  • No severe intercurrent infection NOTE: *Patients who would be excluded from the protocol strictly for laboratory abnormalities may be included at the investigator's discretion after approval by the CCGT Protocol Review committee and the FDA reviewer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608309

Locations
United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine     Recruiting
      Houston, Texas, United States, 77030
      Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor     713-798-1297        
Methodist Hospital     Recruiting
      Houston, Texas, United States, 77030
      Contact: Diana Cooper-Havlik     832-824-4594        
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital     Recruiting
      Houston, Texas, United States, 77030-2399
      Contact: Diana Cooper-Havlik     832-824-4594     dxcooper@txccc.org    

Sponsors and Collaborators
Baylor College of Medicine

Investigators
Principal Investigator:     Helen E. Heslop, MD     Baylor College of Medicine    
  More Information


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

Study ID Numbers:   CDR0000582813, BCM-H-6676, BCM-ETNA
First Received:   February 1, 2008
Last Updated:   September 22, 2008
ClinicalTrials.gov Identifier:   NCT00608309
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma  
recurrent grade 3 follicular lymphoma  
noncontiguous stage II grade 3 follicular lymphoma  
stage III grade 3 follicular lymphoma  
stage IV grade 3 follicular lymphoma  
noncontiguous stage II grade 2 follicular lymphoma  
recurrent grade 2 follicular lymphoma  
stage III grade 2 follicular lymphoma  
stage IV grade 2 follicular lymphoma  
noncontiguous stage II grade 1 follicular lymphoma  
recurrent grade 1 follicular lymphoma  
stage III grade 1 follicular lymphoma  
stage IV grade 1 follicular lymphoma  
recurrent childhood lymphoblastic lymphoma  
noncontiguous stage II adult diffuse small cleaved cell lymphoma  
recurrent adult diffuse small cleaved cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
recurrent adult diffuse mixed cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage IV adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
recurrent adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma

Study placed in the following topic categories:
Juvenile myelomonocytic leukemia
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Ovarian epithelial cancer
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Mycoses
Preleukemia
Wiskott-Aldrich Syndrome
Multiple myeloma
Neoplasm Metastasis
Acute myeloid leukemia, adult
Ataxia Telangiectasia
Hodgkin Disease
Rhabdomyosarcoma
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, B-cell, chronic
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Acute myelogenous leukemia
Myeloproliferative Disorders

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on November 03, 2008




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