drugset / Trial / NCT00711035
Most Closely HLA Matched Allogeneic Virus Specific Cytotoxic T-Lymphocytes (CTL)
Phase 1/2
Completed
50 enrolled
Baylor College of Medicine
Beth Israel Deaconess Medical Center · collabBoston Children's Hospital · collabBrigham and Women's Hospital · collabChildren's Hospital Los Angeles · collabDuke University · collabHackensack Meridian Health · collabM.D. Anderson Cancer Center · collabMassachusetts General Hospital · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabNational Marrow Donor Program · collabThe Emmes Company, LLC · collabThe Methodist Hospital Research Institute · collabUniversity of California, Los Angeles · collabUniversity of Miami · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-11
- Primary completion
- 2012-10
- Completion
- 2013-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trivirus Specific CTLs | Cell therapy | — | — |