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

April 30, 2008
January 21, 2014
March 2008
February 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Primary endpoints (phase I) - Incidence rate of DLT and AE [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • Primary endpoint (phase II) - Response rate [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00670592 on ClinicalTrials.gov Archive Site
Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
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)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
Drug: HCD122
HCD122
Intervention: Drug: HCD122
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
February 2013
February 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Korea, Republic of,   United Kingdom,   Australia,   Canada,   France,   Germany,   Singapore,   Hong Kong,   Italy
 
NCT00670592
CHCD122A2103, 2007-004888-22
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
XOMA (US) LLC
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals
Novartis
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP