Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
A Phase IA/II, Multi-center, Open-label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies (CHIR-12.12-LYM-01)
2 other identifiers
interventional
111
11 countries
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2008
Longer than P75 for phase_1
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 30, 2008
CompletedFirst Posted
Study publicly available on registry
May 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedDecember 17, 2020
January 1, 2014
4.9 years
April 30, 2008
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary endpoints (phase I) - Incidence rate of DLT and AE
2 years
Primary endpoint (phase II) - Response rate
2 years
Secondary Outcomes (1)
Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression
2 years
Study Arms (1)
HCD122
OTHERInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Pharmaceuticalslead
- XOMA (US) LLCcollaborator
Study Sites (28)
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, 77030-4009, United States
Novartis Investigative Site
Parkville, Victoria, 3050, Australia
Novartis Investigative Site
Prahran, Victoria, 3181, Australia
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Godinne, 5530, Belgium
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Toronto, Ontario, M5G 2M9, Canada
Novartis Investigative Site
Montreal, Quebec, H3T 1E2, Canada
Novartis Investigative Site
Créteil, 94010, France
Novartis Investigative Site
Le Mans, 72015, France
Novartis Investigative Site
Lille, 59 037, France
Novartis Investigative Site
Montpellier, 34295, France
Novartis Investigative Site
Paris, 75475, France
Novartis Investigative Site
Pierre-Benite Cédex, F-69495, France
Novartis Investigative Site
Berlin, 12200, Germany
Novartis Investigative Site
Cologne, 50924, Germany
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Bologna, BO, 40138, Italy
Novartis Investigative Site
Milan, MI, 20133, Italy
Novartis Investigative Site
Pisa, PI, 56126, Italy
Novartis Investigative Site
Singapore, 169608, Singapore
Novartis Investigative Site
Seoul, Korea, 110 744, South Korea
Novartis Investigative Site
Leicester, LE1 5WW, United Kingdom
Novartis Investigative Site
London, EC1A 7BE, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
- STUDY DIRECTOR
Novartis Pharmaceuticlas
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2008
First Posted
May 2, 2008
Study Start
March 1, 2008
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
December 17, 2020
Record last verified: 2014-01