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Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
This study is currently recruiting participants.
Verified by Novartis, March 2009
First Received: April 30, 2008   Last Updated: March 6, 2009   History of Changes
Sponsors and Collaborators: Novartis
XOMA (US) LLC
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00670592
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Primary endpoints (phase I) - Incidence rate of DLT and AE [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Primary endpoint (phase II) - Response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients may be included in the study if they meet all of the following criteria:

  • Patients must have confirmed diagnosis of HL or NHL (follicular, marginal zone / MALT, diffuse large B-cell, or mantle cell) per REAL/WHO classification
  • Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy)
  • Patients must be ≥ 18 years
  • Patients must have life expectancy > 3 months
  • Patient must have adequate laboratory results
  • Patients must have WHO Performance Status grade 0, 1, or 2
  • Patients must have at least one site of measurable disease
  • Patients must have discontinued any previous monoclonal antibody or radioimmunotherapy, and must have recovered fully from the side effects of that treatment prior to beginning study treatment.
  • Patients must be willing and able to sign the informed consent form and comply with the study protocol

Exclusion criteria:

Patients will be excluded from the study if they meet any of the following criteria:

  • Patients who have been treated with any anti-CD40 antibody
  • Patients who have received prior allogeneic stem cell transplant
  • Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
  • Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis
  • Women of child-bearing potential (WCBP) who are pregnant or breast feeding.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670592

Contacts
Contact: Novartis Pharmaceuticlas 800-340-6843

Locations
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
Sponsors and Collaborators
Novartis
XOMA (US) LLC
Investigators
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals
  More Information

No publications provided

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

Keywords provided by Novartis:
HCD122
CD40
NHL
HL

Study placed in the following topic categories:
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Hodgkin's Disease
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Hodgkin Disease

ClinicalTrials.gov processed this record on September 03, 2009