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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Graft Versus Host Disease; Nonneoplastic Condition

Intervention: 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)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Hospital Birmingham

Official(s) and/or principal investigator(s):
Frederick Chen, MD, Principal Investigator, Affiliation: University Hospital Birmingham

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.

Clinical Details

Official title: A Randomised Controlled Phase II Trial of the Adoptive Transfer of Selected Cytomegalovirus-Specific Cytotoxic T Lymphocytes (CMV-CTL) After Allogeneic Stem Cell Transplantation (SCT) in Patients at Risk of CMV Disease

Study design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: CMV reactivation in the first year after ASCT measured by quantitative PCR

Secondary outcome:

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

Detailed description: OBJECTIVES: Primary

- To determine the frequency of cytomegalovirus (CMV) reactivation during the first year

after allogeneic stem cell transplantation (ASCT) in patients at risk for CMV infection treated with adoptive transfer of selected CMV-specific cytotoxic T-lymphocytes. Secondary

- To monitor CMV-specific immune reconstitution within the first year following ASCT in

these patients.

- To determine the time to CMV reactivation in these patients.

- To evaluate the use of antiviral therapy in these patients.

- To determine the incidence of secondary CMV reactivation and CMV disease in patients

treated with this regimen.

- To determine the incidence of acute and chronic graft-versus-host disease.

OUTLINE: This is a multicenter study. After undergoing an allogeneic peripheral blood stem cell transplantation (PBSCT) using an alemtuzumab-based conditioning regimen that also includes radiotherapy, patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cytomegalovirus (CMV)-specific cytotoxic T-lymphocyte infusion

on day 21-90 after allogeneic PBSCT.

- Arm II: Patients undergo standard follow-up care and receive standard antiviral therapy

comprising ganciclovir IV or foscarnet sodium upon detection or confirmation of CMV reactivation. Blood samples are collected to assess CMV viral load by quantitative PCR. After completion of study therapy, patients are followed once a week for 100 days and then once a month for 1 year. PROJECTED ACCRUAL: A total of 18 patients with sibling donors and 21 patients with unrelated donors are accrued for each arm, resulting in a total of 78 patients accrued for this study.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England B15 2SG, United Kingdom; Recruiting
Frederick Chen, MD, Phone: 44-121-253-4174
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: September 2009
Last updated: August 23, 2013

Page last updated: August 20, 2015

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