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

Completed · Phase 1

Conditions studied: Follicular Lymphoma

In brief

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

Key facts

Study ID

NCT01275209

Run by

Novartis Pharmaceuticals

People needed

1

Starts

2011-02-01

Expected to finish

2012-05-01

Last updated by the study team

2020-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana Farber Cancer Institute SC-5 — Boston, Massachusetts, 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, United States
• Sarah Cannon Research Institute SC - 2 — Chattanooga, Tennessee, United States
• Novartis Investigative Site — Prahran, Victoria, Australia
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Torino, TO, Italy
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain

Full record on ClinicalTrials.gov

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