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

Completed · Phase 1/Phase 2

Conditions studied: Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00670592

Run by

Novartis Pharmaceuticals

People needed

111

Starts

2008-03-01

Expected to finish

2013-02-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.