Donor Lymphocytes in Preventing and Treating Cytomegalovirus Infection or Adenovirus Infection in Patients Who Have Undergone Umbilical Cord Blood Transplant - Full Text View

Sponsor:	Baylor College of Medicine
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01017705

Purpose

RATIONALE: Donor lymphocytes that have been treated in the laboratory may help prevent or treat cytomegalovirus infection or adenovirus infection in patients who have undergone umbilical cord blood transplant.

PURPOSE: This phase I trial is studying the side effects and best dose of donor lymphocytes in preventing and treating cytomegalovirus infection or adenovirus infection in patients who have undergone umbilical cord blood transplant.

Condition	Intervention	Phase
Cancer	Biological: allogeneic CMV/AdV-specific cytotoxic T lymphocytes Other: laboratory biomarker analysis	Phase I

Study Type:	Interventional
Study Design:	Supportive Care
Official Title:	Adoptive Transfer of Cord Blood T Cells to Prevent and Treat CMV and Adenovirus Infections After Transplantation

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Cytomegalovirus Infections Hodgkin Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma

U.S. FDA Resources

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

Primary Outcome Measures:

Safety of cytotoxic T-cell lymphocytes (CTL) as assessed by CTEP Active version of the NCI CTCAE at 30-45 days after CTL infusion [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Viral load of cytomegalovirus and adenovirus as assessed by PCR before CTL infusion and then weekly for up to 60 days after CTL infusion [ Designated as safety issue: No ]
Reconstitution of antiviral immunity as assessed by ELISPOT assays or tetramer assays [ Designated as safety issue: No ]
Systemic infections occurring within 6 months of CTL infusion [ Designated as safety issue: No ]
Secondary graft failure as assessed for 30 days after CTL infusion [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	November 2009
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To determine the safety, toxicity, and maximum-tolerated dose of donor-derived cytotoxic T-cell lymphocytes (CTLs) specific for cytomegalovirus (CMV) and adenovirus in patients with or at risk for CMV or adenovirus infection after umbilical cord blood transplantation.

Secondary

To evaluate the feasibility of generating a sufficient number of umbilical cord blood-derived CTLs specific for CMV and adenovirus.
To evaluate the impact of these CTLs on CMV-specific T-lymphocyte immune reconstitution.
To evaluate the impact of these CTLs on adenovirus-specific T-lymphocyte immune reconstitution.
To evaluate the recovery of virus-specific immunity after CTL infusion and its correlation with viral clearance and/or protection from viral infection or disease.

OUTLINE: This is a multicenter study.

Patients receive a single infusion of cytomegalovirus/adenovirus-specific cytotoxic T-cell lymphocytes over 1-2 minutes.

Peripheral blood samples may be collected to phenotype peripheral blood T-cells and to analyze immunological parameters.

After completion of study treatment, patients are followed up periodically for up to 12 months.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Has undergone umbilical cord blood transplantation from an unrelated donor for malignant or nonmalignant disease within the past 30 to 365 days
- Single cord blood unit matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens
- Umbilical cord blood unit cryopreserved in 2 fractions (1 for the primary transplant and 1 to generate cytotoxic T-cell lymphocytes)
Meets the following criteria after transplantation:
- At least 50% donor chimerism in either peripheral blood or bone marrow
- No relapse of original disease
At risk for or has cytomegalovirus (CMV) or adenovirus disease or reactivation
No evidence of graft-vs-host disease > grade II
No grade 3 or 4 or primary myelofibrosis
No active CNS disease

PATIENT CHARACTERISTICS:

Karnofsky or Lansky performance status 70-100%
Life expectancy > 30 days
ANC > 500/μL
Creatinine ≤ 3 times normal for age
Direct bilirubin < 3 mg/dL
AST < 5 times upper limit of normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after completion of study treatment
No severe renal or hepatic disease
Not on fractional inspired oxygen of > 60%
No other uncontrolled infection (except for CMV and/or adenovirus and/or Epstein-Barr virusemia in the absence of post-transplant lymphoproliferative disorder)
- Patients with bacterial infections are eligible provided they are receiving definitive therapy and have no signs of progressing infection* for 72 hours before study enrollment
- Patients with fungal infections are eligible provided they are receiving definitive systemic antifungal therapy and have no signs of progressing infection* for 1 week before study enrollment NOTE: *Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent prednisone > 0.5 mg/kg/day

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017705

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

Sponsors and Collaborators

Baylor College of Medicine

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Catherine Bollard

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

Responsible Party:	Dan L. Duncan Cancer Center at Baylor College of Medicine ( Catherine Bollard )
Study ID Numbers:	CDR0000659669, BCM-H-23668
Study First Received:	November 20, 2009
Last Updated:	January 6, 2010
ClinicalTrials.gov Identifier:	NCT01017705 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cytomegalovirus infection
adenovirus infection
cytomegalovirus infection
adenovirus infection
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma

stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma

Additional relevant MeSH terms:

Communicable Diseases
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Adenoviridae Infections
Infection
Herpesviridae Infections
Virus Diseases

Lymphatic Diseases
Neoplasms
Lymphoma, Large-Cell, Immunoblastic
Cytomegalovirus Infections
DNA Virus Infections
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on February 08, 2010