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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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
XOMA (US) LLC
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00670592
First received: April 30, 2008
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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:

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 ]

Enrollment: 111
Study Start Date: March 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670592

  Show 28 Study Locations
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: May 15, 2013
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
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013