Non Hodgkin Lymphoma Clinical Trial

Study of HCD122 in Adults With Non-Hodgkin’s or Hodgkin’s Lymphoma Who Have Progressed After at Least Two Prior Therapies

Summary

This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Patients may be included in the study if they meet all of the following criteria:

Patients must have confirmed diagnosis of HL or NHL (follicular, marginal zone / MALT, diffuse large B-cell, or mantle cell) per REAL/WHO classification
Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy)
Patients must be ≥ 18 years
Patients must have life expectancy > 3 months
Patient must have adequate laboratory results
Patients must have WHO Performance Status grade 0, 1, or 2
Patients must have at least one site of measurable disease
Patients must have discontinued any previous monoclonal antibody or radioimmunotherapy, and must have recovered fully from the side effects of that treatment prior to beginning study treatment.
Patients must be willing and able to sign the informed consent form and comply with the study protocol

Exclusion criteria:

Patients will be excluded from the study if they meet any of the following criteria:

Patients who have been treated with any anti-CD40 antibody
Patients who have received prior allogeneic stem cell transplant
Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis
Women of child-bearing potential (WCBP) who are pregnant or breast feeding.

Other protocol-defined inclusion/exclusion criteria may apply

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

111

Study ID:

NCT00670592

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 27 Locations for this study

See Locations Near You

Northwestern University
Chicago Illinois, 60611, United States
St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)
Beech Grove Indiana, 46107, United States
Dana Farber Cancer Institute SC-5
Boston Massachusetts, 02115, United States
Wake Forest University Baptist Medical Center Dept. of Industry Research (2)
Winston-Salem North Carolina, 27157, United States
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
Houston Texas, 77030, United States
Novartis Investigative Site
Parkville Victoria, 3050, Australia
Novartis Investigative Site
Prahran Victoria, 3181, Australia
Novartis Investigative Site
Gent , 9000, Belgium
Novartis Investigative Site
Godinne , 5530, Belgium
Novartis Investigative Site
Leuven , 3000, Belgium
Novartis Investigative Site
Toronto Ontario, M5G 2, Canada
Novartis Investigative Site
Montreal Quebec, H3T 1, Canada
Novartis Investigative Site
Creteil , 94010, France
Novartis Investigative Site
Le Mans Cedex , 72015, France
Novartis Investigative Site
Lille Cedex , 59 03, France
Novartis Investigative Site
Montpellier cedex 5 , 34295, France
Novartis Investigative Site
Paris , 75475, France
Novartis Investigative Site
Pierre-Benite Cédex , F-694, France
Novartis Investigative Site
Berlin , 12200, Germany
Novartis Investigative Site
Köln , 50924, Germany
Novartis Investigative Site
Hong Kong , , Hong Kong
Novartis Investigative Site
Bologna BO, 40138, Italy
Novartis Investigative Site
Milano MI, 20133, Italy
Novartis Investigative Site
Pisa PI, 56126, Italy
Novartis Investigative Site
Seoul Korea, 110 7, Korea, Republic of
Novartis Investigative Site
Singapore , 16960, Singapore
Novartis Investigative Site
Leicester , LE1 5, United Kingdom
Novartis Investigative Site
London , EC1A , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

111

Study ID:

NCT00670592

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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