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.
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
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There are 27 Locations for this study
Chicago Illinois, 60611, United States
Beech Grove Indiana, 46107, United States
Boston Massachusetts, 02115, United States
Winston-Salem North Carolina, 27157, United States
Houston Texas, 77030, United States
Parkville Victoria, 3050, Australia
Prahran Victoria, 3181, Australia
Gent , 9000, Belgium
Godinne , 5530, Belgium
Leuven , 3000, Belgium
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Creteil , 94010, France
Le Mans Cedex , 72015, France
Lille Cedex , 59 03, France
Montpellier cedex 5 , 34295, France
Paris , 75475, France
Pierre-Benite Cédex , F-694, France
Berlin , 12200, Germany
Köln , 50924, Germany
Hong Kong , , Hong Kong
Bologna BO, 40138, Italy
Milano MI, 20133, Italy
Pisa PI, 56126, Italy
Seoul Korea, 110 7, Korea, Republic of
Singapore , 16960, Singapore
Leicester , LE1 5, United Kingdom
London , EC1A , United Kingdom
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