Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma

Follicular Lymphoma Clinical Trial

— LIFT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275209
• Other study ID #: CHCD122A2104
• Secondary ID: 2010-022350-17
• Status: Completed
• Phase: Phase 1
• Start date: February 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• HCD122

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Prahran	Victoria
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Leuven
Canada	Novartis Investigative Site	Toronto	Ontario
France	Novartis Investigative Site	Paris
Italy	Novartis Investigative Site	Torino	TO
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Madrid
United States	Dana Farber Cancer Institute SC-5	Boston	Massachusetts
United States	Sarah Cannon Research Institute SC - 2	Chattanooga	Tennessee
United States	Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)	Detroit	Michigan
United States	Duke University Medical Center Duke Hem & Onc	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of dose-limiting toxicities and adverse events		2 years
Secondary	Response rate		2 years

External Links

•   Results for CHCD122A2104 can be found on the Novartis Clinical Trial Results Website