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 ongoing, but not recruiting participants.

First Received on April 30, 2008. Last Updated on August 31, 2011 History of Changes

Sponsor:	Novartis
Collaborator:	XOMA (US) LLC
Information provided by (Responsible Party):	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:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

MedlinePlus related topics: Hodgkin Disease Lymphoma

U.S. FDA Resources

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:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HCD122	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

Locations

United States, Indiana
St. Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Texas
MD Anderson Cancer Center /Dept. of Lymphoma/Myeloma
Houston, Texas, United States, 77030
Australia, Victoria
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Belgium
Novartis Investigative Site
Leuven, Belgium
Canada, Quebec
Jewish General Hospital/Lady Davis Institute for Medical Researc/Sir Mortimer B Davis Jewish Hospital
Montreal, Quebec, Canada
France
Novartis Investigative Site
Le Mans Cedex 2, France
Novartis Investigative Site
Montpellier, France
Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Cologne, Germany
Italy
Novartis Investigative Site
Bologna, Italy
Novartis Investigative Site
Milano, Italy

Sponsors and Collaborators

Novartis

XOMA (US) LLC

Investigators

Study Director:

Novartis Pharmaceuticlas

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00670592 History of Changes
Other Study ID Numbers:	CHCD122A2103
Study First Received:	April 30, 2008
Last Updated:	August 31, 2011
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

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012