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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT01275209

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 12 Locations for this study

See Locations Near You

Dana Farber Cancer Institute SC-5
Boston Massachusetts, 02115, United States
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)
Detroit Michigan, 48201, United States
Duke University Medical Center Duke Hem & Onc
Durham North Carolina, 27710, United States
Sarah Cannon Research Institute SC - 2
Chattanooga Tennessee, 37404, United States
Novartis Investigative Site
Prahran Victoria, 3181, Australia
Novartis Investigative Site
Gent , 9000, Belgium
Novartis Investigative Site
Leuven , 3000, Belgium
Novartis Investigative Site
Toronto Ontario, M5G 2, Canada
Novartis Investigative Site
Paris , 75475, France
Novartis Investigative Site
Torino TO, 10126, Italy
Novartis Investigative Site
Barcelona Cataluña, 08035, Spain
Novartis Investigative Site
Madrid , 28046, Spain

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT01275209

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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