Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
NCT ID: NCT00670592
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
111 participants
INTERVENTIONAL
2008-03-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HCD122
HCD122
Interventions
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HCD122
Eligibility Criteria
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Inclusion 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 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.
18 Years
ALL
No
Sponsors
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XOMA (US) LLC
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticlas
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Northwestern University
Chicago, Illinois, United States
St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)
Beech Grove, Indiana, United States
Dana Farber Cancer Institute SC-5
Boston, Massachusetts, United States
Wake Forest University Baptist Medical Center Dept. of Industry Research (2)
Winston-Salem, North Carolina, United States
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
Houston, Texas, United States
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Prahran, Victoria, Australia
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
Godinne, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Créteil, , France
Novartis Investigative Site
Le Mans, , France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Pierre-Benite Cédex, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Hong Kong, , Hong Kong
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Pisa, PI, Italy
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Leicester, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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Related Links
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Results for CHCD122A2103 from the Novartis Clinical Trials website
Other Identifiers
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2007-004888-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CHCD122A2103
Identifier Type: -
Identifier Source: org_study_id
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