Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies

Non-Hodgkin's Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670592
• Other study ID #: CHCD122A2103
• Secondary ID: 2007-004888-22
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2008
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• HCD122

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Parkville	Victoria
Australia	Novartis Investigative Site	Prahran	Victoria
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Godinne
Belgium	Novartis Investigative Site	Leuven
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Le Mans Cedex
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Montpellier cedex 5
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Pierre-Benite Cédex
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Köln
Hong Kong	Novartis Investigative Site	Hong Kong
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Pisa	PI
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Singapore	Novartis Investigative Site	Singapore
United Kingdom	Novartis Investigative Site	Leicester
United Kingdom	Novartis Investigative Site	London
United States	St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)	Beech Grove	Indiana
United States	Dana Farber Cancer Institute SC-5	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)	Houston	Texas
United States	Wake Forest University Baptist Medical Center Dept. of Industry Research (2)	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	XOMA (US) LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Hong Kong,  Italy,  Korea, Republic of,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoints (phase I) - Incidence rate of DLT and AE		2 years
Primary	Primary endpoint (phase II) - Response rate		2 years
Secondary	Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression		2 years

External Links

•   Results for CHCD122A2103 from the Novartis Clinical Trials website