T Lymphocytes in Treating Patients Undergoing a Donor Bone Marrow Transplant - Full Text View

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	Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes Genetic: polymerase chain reaction Other: immunological diagnostic method Procedure: adjuvant therapy	Phase I

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

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

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:	CDR0000582813, BCM-H-6676, BCM-ETNA
Study First Received:	February 1, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00608309 History of Changes
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:

Chronic Myelomonocytic Leukemia
Blast Crisis
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Follicular Lymphoma
Mycoses
Acute Myelocytic Leukemia
Preleukemia
Wiskott-Aldrich Syndrome
Acute Myeloid Leukemia, Adult
Leukemia, Lymphocytic, Chronic, B-Cell
Wilms' Tumor
Neoplasm Metastasis
Ataxia Telangiectasia
Hodgkin Disease

Rhabdomyosarcoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Testicular Cancer
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Hairy Cell Leukemia
Adjuvants, Immunologic
Myeloproliferative Disorders
Juvenile Myelomonocytic Leukemia
Breast Neoplasms
Leukemia, Myeloid
Testicular Neoplasms
Multiple Myeloma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases

Lymphoma, Large-Cell, Immunoblastic
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009