|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Baylor College of Medicine |
|---|---|
| Collaborators: |
Texas Children's Hospital The Methodist Hospital System Brigham and Women's Hospital Massachusetts General Hospital M.D. Anderson Cancer Center National Marrow Donor Program The EMMES Corporation Duke University Beth Israel Deaconess Medical Center Children's Hospital Los Angeles National Heart, Lung, and Blood Institute (NHLBI) Children's Hospital Boston University of Miami Hackensack University Medical Center University of California, Los Angeles |
| Information provided by (Responsible Party): | Helen Heslop, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00711035 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenovirus Infection EBV Infection |
Biological: Most Closely Matched CTLs with Adenovirus |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Most Closely HLA Matched Allogeneic Virus Specific Cytotoxic T-Lymphocytes (CTL) to Treat Persistent Reactivation Or Infection With Adenovirus, CMV and EBV After Hemopoietic Stem Cell Transplantation (HSCT) |
| Estimated Enrollment: | 45 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
If a patient has a partial response they are eligible to receive up to 4 additional doses at biweekly intervals. These doses would come from the original infused line if sufficient vials were available but may come from another line if there are insufficient cells in the original line.
|
Biological: Most Closely Matched CTLs with Adenovirus
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. |
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be eligible following any type of allogeneic transplant if they have CMV, adenovirus or EBV infection persistent to standard therapy (as defined below).
CMV, adenovirus or EBV infection persistent despite standard therapy
Exclusion Criteria:
For initial CTL and subsequent infusions:
Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.
Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Contacts and Locations| Contact: Helen Heslop, MD | 832-824-4662 | hheslop@bcm.tmc.edu |
| Contact: Malcolm Brenner, MB, PhD | 832-824-4671 | mkbrenne@txccc.org |
| United States, California | |
| Children's Hospital of Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Neena Kapoor, MD 323-669-2546 nkapoor@chla.usc.edu | |
| Principal Investigator: Neena Kapoor, MD | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Bimalangshu Dey, MD 617-724-1124 BDEY@partners.org | |
| Principal Investigator: Bimalangshu Dey, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Paul Martin, MD 919-668-1100 paul.martin@duke.edu | |
| Principal Investigator: Paul Martin, MD, PhD | |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Helen E Heslop, MD 832-824-4662 heheslop@txccc.org | |
| Principal Investigator: Helen Heslop, MD | |
| Sub-Investigator: George Carrum, MD | |
| Sub-Investigator: Robert A Krance, MD | |
| Sub-Investigator: Malcolm K Brenner, MD | |
| Sub-Investigator: Cliona M Rooney, MD | |
| Sub-Investigator: Adrian P Gee, MD | |
| Sub-Investigator: Kathryn S Leung, MD | |
| Sub-Investigator: Catherine M Bollard, MD | |
| Sub-Investigator: Ann M Leen, MD | |
| Sub-Investigator: Alana A Kennedy-Nasser, MD | |
| Sub-Investigator: Rammurti T Kamble, MD | |
| Sub-Investigator: Caridad A Martinez, MD | |
| Sub-Investigator: Carlos A Ramos, MD | |
| The Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77073 | |
| Contact: Helen E Heslop, MD 832-824-4662 heheslop@txccc.org | |
| Principal Investigator: Helen E Heslop, MD | |
| Sub-Investigator: Catherine M Bollard, MD | |
| Sub-Investigator: Malcolm Brenner, MD | |
| Sub-Investigator: George Carrum, MD | |
| Sub-Investigator: Rammurti Kamble, MD | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Helen E Heslop, MD 832-824-4662 hheslop@bcm.tmc.edu | |
| Principal Investigator: Helen E Heslop, MD | |
| Principal Investigator: | Helen Heslop, MD | Baylor College of Medicine |
More Information
| Responsible Party: | Helen Heslop, Principal Investigator, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00711035 History of Changes |
| Other Study ID Numbers: | 22994-CHALLAH, CHALLAH, U54HL081007 |
| Study First Received: | June 20, 2008 |
| Last Updated: | December 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
CMV Adenovirus EBV non-myeloablative transplants Prior allogeneic hematopoietic stem cell transplant |
|
Adenoviridae Infections Epstein-Barr Virus Infections DNA Virus Infections Virus Diseases |
Herpesviridae Infections Tumor Virus Infections Neoplasms, Experimental Neoplasms |