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| Sponsor: | Baylor College of Medicine |
|---|---|
| Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) Texas Children's Hospital The Methodist Hospital System |
| Information provided by: | 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Allogeneic Transplant Cytomegalovirus Adenovirus Infection EBV Infection |
Biological: Most Closely Matched CTLs with Adenovirus |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| 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 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment: Experimental
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:
CMV, adenovirus or EBV infection persistent despite standard therapy
Donors will be eligible if they meet eligibility criteria for blood donors on history and exam by a transplant donor physician and have negative infectious diseases testing for HIV-1 antibody, HIV-2 antibody, HIV NAT, HTLV-1/2 antibodies, HBs antigen, HBc antibody, HCV NAT, RPR, West Nile virus NAT, and Chagas testing
Exclusion Criteria:
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.
Donors will be ineligible if they do not meet eligibility criteria for blood donors on the donor questionaire or have positive infectious diseases testing on any of the tests outlined in the inclusion criteria
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 Szabolcs, MD 919-668-1122 szabo001@mc.duke.edu | |
| Principal Investigator: Paul Szabolcs, MD | |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Helen Heslop, MD | |
| The Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77073 | |
| Principal Investigator: | Helen Heslop, MD | Baylor College of Medicine |
More Information
| Responsible Party: | BCM/CAGT ( Helen Heslop, MD ) |
| Study ID Numbers: | 22994, CHALLAH |
| Study First Received: | June 20, 2008 |
| Last Updated: | April 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00711035 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
CMV Adenovirus EBV non-myeloablative transplants Prior allogeneic hematopoietic stem cell transplant |
|
Virus Diseases Communicable Diseases Neoplasms Adenoviridae Infections Tumor Virus Infections Cytomegalovirus Infections |
DNA Virus Infections Epstein-Barr Virus Infections Infection Neoplasms, Experimental Herpesviridae Infections |