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| 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 1 |
| Study Type: | Interventional |
| Study Design: | 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:
Pts 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
The informed consent process will begin at recognition of subject eligibility and consent will be obtained per institutional practices before study therapy is initiated. Subjects will initially sign a screening consent to enable a search to be made for a line. If a line is available they will sign the treatment consent.
Up to 4 additional doses can be administered if a partial response is obtained and patient meets eligibility criteria for subsequent infusions. The minimum interval between subsequent infusions is 2 weeks.
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.
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.
Donors will be ineligible if they do not meet eligibility criteria for blood donors on the donor questionnaire 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 | heheslop@txch.org |
| Contact: Yu-Feng Lin | 832-824-4258 | yxlin@txch.org |
| United States, California | |
| Children's Hospital of Los Angeles | Completed |
| Los Angeles, California, United States, 90027 | |
| University of Californa Los Angeles (UCLA) | Withdrawn |
| Los Angeles, California, United States | |
| United States, Florida | |
| University of Miami | Completed |
| Coral Gables, Florida, United States | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Completed |
| Boston, Massachusetts, United States, 02115 | |
| United States, New Jersey | |
| Hackensack University | Completed |
| Bergen County, New Jersey, United States | |
| United States, North Carolina | |
| Duke University Medical Center | Completed |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Helen E Heslop, MD 832-824-4662 heheslop@txch.org | |
| Contact: Yu-Feng Lin 832-824-4258 yxlin@txch.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 | Completed |
| Houston, Texas, United States, 77030 | |
| 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: | April 16, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
|
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 |