Non Hodgkin Lymphoma Clinical Trial
Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma
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
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There are 12 Locations for this study
Boston Massachusetts, 02115, United States
Detroit Michigan, 48201, United States
Durham North Carolina, 27710, United States
Chattanooga Tennessee, 37404, United States
Prahran Victoria, 3181, Australia
Gent , 9000, Belgium
Leuven , 3000, Belgium
Toronto Ontario, M5G 2, Canada
Paris , 75475, France
Torino TO, 10126, Italy
Barcelona Cataluña, 08035, Spain
Madrid , 28046, Spain
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