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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 has been completed.
Sponsor:
Collaborator:
XOMA (US) LLC
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00670592
First received: April 30, 2008
Last updated: January 21, 2014
Last verified: January 2014
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 (CHIR-12.12-LYM-01)

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 ]

Enrollment: 111
Study Start Date: March 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)
Beech Grove, Indiana, United States, 46107
United States, Massachusetts
Dana Farber Cancer Institute SC-5
Boston, Massachusetts, United States, 02115
United States, North Carolina
Wake Forest University Baptist Medical Center Dept. of Industry Research (2)
Winston-Salem, North Carolina, United States, 27157
United States, Texas
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
Houston, Texas, United States, 77030-4009
Australia, Victoria
Novartis Investigative Site
Parkville, Victoria, Australia, 3050
Novartis Investigative Site
Prahran, Victoria, Australia, 3181
Belgium
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Godinne, Belgium, 5530
Novartis Investigative Site
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
France
Novartis Investigative Site
Creteil, France, 94010
Novartis Investigative Site
Le Mans Cedex, France, 72015
Novartis Investigative Site
Lille Cedex, France, 59 037
Novartis Investigative Site
Montpellier cedex 5, France, 34295
Novartis Investigative Site
Paris, France, 75475
Novartis Investigative Site
Pierre-Benite Cédex, France, F-69495
Germany
Novartis Investigative Site
Berlin, Germany, 12200
Novartis Investigative Site
Köln, Germany, 50924
Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
Italy
Novartis Investigative Site
Bologna, BO, Italy, 40138
Novartis Investigative Site
Milano, MI, Italy, 20133
Novartis Investigative Site
Pisa, PI, Italy, 56126
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 110 744
Singapore
Novartis Investigative Site
Singapore, Singapore, 169608
United Kingdom
Novartis Investigative Site
Leicester, United Kingdom, LE1 5WW
Novartis Investigative Site
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Novartis Pharmaceuticals
XOMA (US) LLC
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00670592     History of Changes
Other Study ID Numbers: CHCD122A2103, 2007-004888-22
Study First Received: April 30, 2008
Last Updated: January 21, 2014
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:
HCD122
CD40
NHL
HL

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

ClinicalTrials.gov processed this record on November 20, 2014