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| Sponsored by: |
CureTech Ltd |
|---|---|
| Information provided by: | CureTech Ltd |
| ClinicalTrials.gov Identifier: | NCT00532259 |
Purpose
Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Large Cell, Diffuse Lymphoma, Mixed Cell, Diffuse Primary Mediastinal Large B-Cell Lymphoma Transformed Follicular Lymphoma Relapsed |
Drug: CT-011 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients With Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantation |
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Scripps Cancer Center | Recruiting |
| San Diego, California, United States, 92121 | |
| Contact: Debbie Deseno, BSN 858-657-4075 deseno.debbie@scrippshealth.org | |
| Contact: Laurie Sampson, BSN 858-554-9379 sampson.laurie@scrippshealth.org | |
| Principal Investigator: Alan Saven, M.D | |
| Moores UCSD Cancer Center | Recruiting |
| La Jolla,, California, United States, 92093-0706 | |
| Contact: Sue Corringham, RN 858-822-6387 scorringham@ucsd.edu | |
| Contact: Peter Holman, MD 858-822-6600 pholman@ucsd.edu | |
| Principal Investigator: Peter Holman, MD | |
| United States, Illinois | |
| Northwestestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611-3008 | |
| Contact: Simbi Acharya, MS 312-695-1383 s-acharya@northwestern.edu | |
| Contact: Sara Duffey (312) 695-1354 s-duffey@northwestern.edu | |
| Principal Investigator: Leo I. Gordon, M.D | |
| The University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Kathy Conner, RN 773-702-2034 kconner@medicine.bsd.uchicago.edu | |
| Contact: Dale Rush, CRA 773-834-7424 drush@medicine.bsd.uchicago.edu | |
| Principal Investigator: Koen van Besien, MD | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Kathleen McDermott, RN 617-632-3332 Kathleen_McDermott@dfci.harvard.edu | |
| Contact: Kären Fulton, CRC 617-582-8054 Karen_Fulton@dfci.harvard.edu | |
| Principal Investigator: Philippe Armand, MD, PhD | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0473 | |
| Contact: Charles D Leister 734-936-2740 cleister@umich.edu | |
| Contact: Cancer Center Answer Line 1-800-865-1125 | |
| Principal Investigator: Erica Campagnaro, MD | |
| Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Marie A. Ventimiglia, B.S. 313-576-9271 ventimim@karmanos.org | |
| Contact: Stephanie Bower, RN, CCRP 313-576-9276 bowers@karmanos.org | |
| Principal Investigator: Joseph P. Uberti, M.D., Ph.D. | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Donna Adams adams068@mc.duke.edu | |
| Principal Investigator: David A. Rizzieri, MD | |
| United States, Ohio | |
| Ohio State University | Recruiting |
| Colombus, Ohio, United States, 43210 | |
| Contact: EmergingMed Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
| Principal Investigator: Steven Devine, MD | |
| United States, Pennsylvania | |
| Temple University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111-2442 | |
| Contact: Patricia E. Bristol, RN, BSN 215-214-6982 Patricia.Bristol@tuhs.temple.edu | |
| Contact: Lisa E. Matta, RN, MSN 215-214-3118 MattaL@tuhs.temple.edu | |
| Principal Investigator: Kenneth Mangan, MD | |
| United States, South Carolina | |
| Cancer Center of the Carolinas | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Lisa M Johnson, RN, BSN 864-679-3966 lisa.johnson@usoncology.com | |
| Contact: Julie Martin, RN, BSN (864) 679-3966 julie.martin@usoncology.com | |
| Principal Investigator: Suzanne Fanning, MD | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Raymond Hernandez, BS 615-329-7274 ext 7489 raymond.hernandez@scresearch.net | |
| Contact: Meredith Zimlich 615-329-7274 ext 7245 Meredith.zimlich@scresearch.net | |
| Principal Investigator: Jesus Berdeja, MD | |
| United States, Texas | |
| M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Becky A. McMullin, RN, BSN 713-745-4371 bmcmulli@mdanderson.org | |
| Principal Investigator: Chitra Hosing, M.D. | |
| Israel | |
| Chaim Sheba Medical Center | Recruiting |
| Tel Hashomaer, Ramat Gan, Israel | |
| Contact: Arnon Nagler, M.D 972 (3) 5305830 a.nagler@sheba.health.gov.il | |
| Rambam Medical Center | Recruiting |
| Haifa, Israel | |
| Contact: Limor Dan, MA +972 4 8543426 l_dan@rambam.health.gov.il | |
| Principal Investigator: Jacob M Rowe, M.D. | |
| Hadassah Medical Organization | Recruiting |
| Jerusalem, Israel | |
| Contact: Reuven Or, M.D. 972-2-6773857 reuvenor@hadassah.org.il | |
| Principal Investigator: Reuven Or, M.D. | |
| Principal Investigator: | Leo I Gordon, MD | Northwestern University Feinberg School of Medicine |
| Principal Investigator: | Arnon Nagler, MD | Chaim Sheba Medical Center |
More Information
| Responsible Party: | CureTech Ltd. ( Cilnical Trial Coordinator ) |
| Study ID Numbers: | CT-2007-01 |
| Study First Received: | September 19, 2007 |
| Last Updated: | January 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00532259 |
| Health Authority: | United States: Food and Drug Administration; Israel: Ministry of Health |
|
Lymphoma, Large B-Cell, Diffuse Transformed Follicular Lymphoma Stem cell transplantation Relapsed Refractory |
|
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Lymphoma, Follicular Lymphoma, B-Cell Lymphoma, large-cell Antibodies, Monoclonal Lymphatic Diseases |
Antibodies B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma Immunoglobulins |
|
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |
