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Sponsors and Collaborators: |
Novartis XOMA (US) LLC |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00670592 |
This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.
Condition | Intervention | Phase |
---|---|---|
Non-Hodgkin's Lymphoma Hodgkin's Lymphoma |
Drug: HCD122 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase IA/II, Multi-Center, Open-Label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies |
Estimated Enrollment: | 50 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 | Drug: HCD122 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Patients may be included in the study if they meet all of the following criteria:
Exclusion criteria:
Patients will be excluded from the study if they meet any of the following criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis Pharmaceuticlas | 800-340-6843 |
United States, Indiana | |
St. Francis Hospital and Health Centers | Recruiting |
Beech Grove, Indiana, United States, 46107 | |
Contact: Muhammad Jamal 317-782-7820 | |
Principal Investigator: Maureen Cooper, M.D. | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Nicole Gallo 617-632-4894 | |
Principal Investigator: Arnold Freedman, M.D. | |
Massachusetts General Hospital Cancer Center | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Kathleen Shea 617-789-6100 | |
Principal Investigator: Jeremy Abramson, M.D. | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Michelle Kim 617-661-7000 | |
Principal Investigator: Robin Joyce, M.D. | |
United States, Texas | |
MD Anderson Cancer Center /Dept. of Lymphoma/Myeloma | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Mary Joy Liboon, BSN/RN 713-792-3510 | |
Principal Investigator: Michelle Fanale, M.D. | |
Australia, Victoria | |
Novartis Investigative Site | Recruiting |
Parkville, Victoria, Australia | |
Novartis Investigative Site | Recruiting |
Melbourne, Victoria, Australia | |
Belgium | |
Novartis Investigative Site | Recruiting |
Leuven, Belgium | |
Canada, Quebec | |
Jewish General Hospital/Lady Davis Institute for Medical Researc/Sir Mortimer B Davis Jewish Hospital | Recruiting |
Montreal, Quebec, Canada | |
Principal Investigator: Sarit Assouline, M.D. | |
France | |
Novartis Investigative Site | Recruiting |
Le Mans Cedex 2, France | |
Novartis Investigative Site | Recruiting |
Montpellier, France | |
Germany | |
Novartis Investigative Site | Recruiting |
Berlin, Germany | |
Novartis Investigative Site | Recruiting |
Cologne, Germany | |
Italy | |
Novartis Investigative Site | Recruiting |
Bologna, Italy | |
Novartis Investigative Site | Recruiting |
Milano, Italy |
Study Director: | Novartis Pharmaceuticlas | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( Novartis Oncology Clinical Trials Line Hotline ) |
Study ID Numbers: | CHCD122A2103 |
Study First Received: | April 30, 2008 |
Last Updated: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00670592 History of Changes |
Health Authority: | United States: Food and Drug Administration; Belgium: Agence Fédérale des Médicaments et des Produits de Santé; Germany: Federal Institute for Drugs and Medical Devices; Australia: Department of Health and Ageing Therapeutic Goods Administration; Italy: The Italian Medicines Agency; France: Afssaps - French Health Products Safety Agency |
HCD122 CD40 NHL HL |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hodgkin's Disease |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Hodgkin Disease Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Hodgkin Disease |