Most Closely HLA Matched Allogeneic Virus Specific Cytotoxic T-Lymphocytes (CTL)

Summary

This trial is designed to evaluate the feasibility, safety and efficacy of most closely HLA-matched multivirus specific CTL lines (CHM-CTLs) in HSCT patients with EBV, CMV or adenovirus infections that are persistent despite standard therapy.

The primary objective of the study is to assess safety and feasibility of administering CTLs. Survival data will be collected by asking the transplant center to submit the routine Transplant Essential Data form that is sent to the Stem Cell Transplant Outcomes Database at 100 days and 1 year and includes data on survival status and other outcome measures.

Conditions

• Adenovirus Infection
• EBV Infection

Interventions

BIOLOGICAL

Trivirus Specific CTLs for EBV, CMV and Adenovirus Infection

Follow-up Assessments: The timing of follow-up visits is based on the date of CTL infusion. If a patient has multiple CTL doses the schedule resets again at the beginning so follow up relates to the last CTL dose. Follow up will occur at 7 days, 14 days, 21 days, 28 days, 42 days, 90 days, 180 days, and 365 days post enrollment.

Sponsors & Collaborators

• The Methodist Hospital Research Institute

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• National Marrow Donor Program

  collaborator OTHER

• The Emmes Company, LLC

  collaborator INDUSTRY

• Duke University

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Boston Children's Hospital

  collaborator OTHER

• University of Miami

  collaborator OTHER

• Hackensack Meridian Health

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Helen Heslop, MD · Baylor College of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2012-10-31

Completion

2013-08-31

Countries

• United States

Study Locations