Clinical trial NCT01275209: Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma
Official title: A Phase Ib, Multicenter, Open-label Study of HCD122 Administered Intravenously in Combination With Bendamustine in Patients With CD40+ Follicular Lymphoma Who Are Refractory to Rituximab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Follicular Lymphoma
Keywords: HCD122
Lucatumumab
CD40
Follicular Lymphoma
Non-Hodgkin's Lymphoma
Antibody
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-12
Enrollment: 1
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 will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization \[REAL/WHO\] classification
* Documented CD40+ follicular lymphoma
* Measurable lesion
* Refractory to rituximab
* Prior treatment with at least 1 chemotherapeutic regimen
* 18 years or older
* WHO Performance Status grade 0, 1, or 2
* Life expectancy \> 3 months
* Obtained written informed consent

Exclusion Criteria:

* Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL)
* History of another primary malignancy that is currently clinically significant or currently requires active intervention
* Prior allogeneic stem cell transplantation
* Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
* Impaired cardiac function or clinically significant cardiac disease
* History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis
* History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment.
* Known diagnosis of human immunodeficiency virus (HIV) infection
* Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C
* Ongoing corticosteroid use (\>10 mg/day prednisone or equivalent)
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Incidence rate of dose-limiting toxicities and adverse events
timeFrame: 2 years
Secondary outcomes:
measure: Response rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute SC-5
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center Duke Hem & Onc
state: North Carolina
city: Chattanooga
country: United States
facility: Sarah Cannon Research Institute SC - 2
state: Tennessee
city: Prahran
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Gent
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: Paris
country: France
facility: Novartis Investigative Site
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: