Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants

NCT00673868 | Completed Phase 1 DMC

• 1 other identifier: 26769
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the immunologic and virologic effects of prophylactic CMV specific CTL in recipients of T cell depleted stem cell transplant (TCD SCT) at Duke University Medical Center (DUMC), by measuring levels of CMV DNA and virus specific T cell precursors at intervals post-infusion.

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

• The primary objective is to characterize CMV specific immunity in subjects receiving and in those randomized to not receive CMV CTL. We will characterize CMV CTLp frequencies and bulk cytotoxicity at days 30 and 60 post infusion.

  one year

Secondary Outcomes (3)

• To characterize the time to develop CMV specific immunity in pts. receiving and not receiving CTL by assessing CMV CTL

  one year

• To determine the CMV epitopes recognized by donors

  one year

• To characterize the levels of CMV DNA in recipients of CMV CTL and non CTL

  one year

Study Arms (2)

1

EXPERIMENTAL

Biological: CMV Specific Cytotoxic T Lymphocytes

2

NO INTERVENTION

Interventions

CMV Specific Cytotoxic T Lymphocytes BIOLOGICAL

CMV Specific Cytotoxic T Lymphocytes will be infused between days 30 and 40 post-transplant at a dose ranging from 2- 5 x e5 cells/kg.

1

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any allogeneic stem cell transplant recipient \> 2 years of age who is CMV sero-positive and has a CMV sero-positive donor,
• Bilirubin \< 2.0 mg/dl; SGOT/SGPT \< 2.5 X normal.
• Creatinine clearance \> 50 cc/min as estimated by patient's serum creatinine, weight, and age.
• Pulse oximetry \> 95% on no supplemental oxygen.
• ECOG performance status \< 2; for patients, 16 years of age, Lansky performance status \>70%.

You may not qualify if:

• Sero-negative patients with a history of GVHD of grade II or greater by the Glucksberg crireria (protocol Appendix I) at or prior to day +30 of current stem cell transplant are excluded.
• Patients who have received a prior stem cell transplant are excluded.
• Patients who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month.
• Subjects receiving systemic immunosuppressive agents for the treatment of GVHD at the time of the CTL infusion will be excluded from receiving CTL, and subjects randomized to not receive CTL will also be removed from study if at the time of the CTL infusion they require systemic immunosuppression for treatment of GVHD
• Donors must be negative for HIV-1, HIV-2, and HTLV-2, and have passed all screening tests for hepatitis.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State University

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Kenneth G. Lucas, MD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 7, 2008
• Study Start: October 1, 2007
• Primary Completion: August 6, 2008
• Study Completion: August 6, 2008
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

US (1)