T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant

NCT00986557 | Unknown Phase 2

• 4 other identifiers: CDR0000650654CRC-TU-ACE-CMV53325562EU-20974
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce cytomegalovirus infection during the first year after a donor stem cell transplant. PURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it works compared with standard therapy in treating patients at risk of cytomegalovirus infection after a donor stem cell transplant.

Conditions

Graft Versus Host Disease; Nonneoplastic Condition

Keywords

cytomegalovirus infection; graft versus host disease

Outcome Measures

Primary Outcomes (1)

• CMV reactivation in the first year after ASCT measured by quantitative PCR

Secondary Outcomes (5)

• CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT

• Time to CMV reactivation

• Use of antiviral therapy

• Incidence of secondary CMV reactivation and CMV disease

• Incidence of acute and chronic graft-versus-host disease

Interventions

adoptive immunotherapy BIOLOGICAL

alemtuzumab BIOLOGICAL

in vitro-treated peripheral blood lymphocyte therapy BIOLOGICAL

foscarnet sodium DRUG

ganciclovir DRUG

polymerase chain reaction GENETIC

allogeneic hematopoietic stem cell transplantation PROCEDURE

infection prophylaxis and management PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

standard follow-up care PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Planning allogeneic peripheral blood stem cell transplantation (PBSCT) using a conditioning regimen containing alemtuzumab and radiotherapy * Sibling or matched unrelated donor available * Patients and donor matched for ≥ one of the following HLA alleles: * HLA-A\*0101 * HLA\*0201 * HLA-A\*1101 * HLA-A\*2402 * HLA-B\*0702 * HLA-B\*0801 * HLA-B\*3502 * No donors whose stem cells have already been collected and cryopreserved prior to transplant * Patient and donor must be CMV seropositive * Stem cell harvests ≥ 4.0 x 10\^6 CD34 cells/kg PATIENT CHARACTERISTICS: * See Disease Characteristics PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior bone marrow transplantation * No concurrent participation in another therapeutic transplantation study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital Birmingham: lead

Study Sites (1)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2SG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease; Cytomegalovirus Infections

Interventions

Immunotherapy, Adoptive; Alemtuzumab; Foscarnet; Ganciclovir; Polymerase Chain Reaction; Therapeutics; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Immunologic Techniques; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphonoacetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Organophosphonates; Organophosphorus Compounds; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleic Acid Amplification Techniques; Genetic Techniques; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Transplantation; Surgical Procedures, Operative

Study Officials

• Frederick Chen, MD

  University Hospital Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2010-04

Locations

GB (1)