NCT Number: NCT00670592
Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Novartis Investigative Site, Parkville, Victoria, Australia
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Primary endpoints (phase I) - Incidence rate of DLT and AE
Time frame: 2 years
-
Primary endpoint (phase II) - Response rate
Time frame: 2 years
Secondary outcomes
-
Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression
Time frame: 2 years
Sponsors and collaborators
Lead sponsor
Novartis Pharmaceuticals
Industry
Collaborators
- XOMA (US) LLC
Registry information
Official study title
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)
Important dates
- Study start
- 2008
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- May 2, 2008
- Registry last updated
- Dec 17, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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