Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma
NCT ID: NCT01275209
Last Updated: 2020-12-08
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
1 participants
INTERVENTIONAL
2011-02-28
2012-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HCD122
HCD122
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HCD122
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CHCD122A2104 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-022350-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CHCD122A2104
Identifier Type: -
Identifier Source: org_study_id