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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Bendamustine Hydrochloride; Rituximab

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