Clinical trial NCT00670592: Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Keywords: HCD122
CD40
NHL
HL
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: XOMA (US) LLC
First posted: 2008-05-02
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Primary endpoints (phase I) - Incidence rate of DLT and AE
timeFrame: 2 years
measure: Primary endpoint (phase II) - Response rate
timeFrame: 2 years
Secondary outcomes:
measure: Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Beech Grove
country: United States
facility: St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)
state: Indiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute SC-5
state: Massachusetts
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center Dept. of Industry Research (2)
state: North Carolina
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
state: Texas
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Prahran
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Godinne
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Creteil
country: France
facility: Novartis Investigative Site
city: Le Mans Cedex
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Pierre-Benite Cédex
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Köln
country: Germany
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Leicester
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticlas
role: STUDY_DIRECTOR
References: