Non-Hodgkin's LymphomaPhase 1/2NCT00670592
Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
A Phase 1/2 study testing HCD122 in people with Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma, run by Novartis Pharmaceuticals at 28 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma
- What is being tested?
- HCD122
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 28 sitesin 11 countries
- Study dates
- Mar 2008to Feb 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
28 sites in 11 countries.
28 sites in 11 countries
France6 sites
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Le Mans, 72015
Novartis Investigative Site
Lille, 59 037
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Paris, 75475
Novartis Investigative Site
Pierre-Benite Cédex, F-69495
United States5 sites
St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)
Beech Grove, Indiana, 46107
Dana Farber Cancer Institute SC-5
Boston, Massachusetts, 02115
Northwestern University
Chicago, Illinois, 60611
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
Houston, Texas, 77030-4009
Wake Forest University Baptist Medical Center Dept. of Industry Research (2)
Winston-Salem, North Carolina, 27157
Belgium3 sites
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Godinne, 5530
Novartis Investigative Site
Leuven, 3000
Italy3 sites
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Pisa, PI, 56126
Australia2 sites
Novartis Investigative Site
Parkville, Victoria, 3050
Novartis Investigative Site
Prahran, Victoria, 3181
Canada2 sites
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Germany2 sites
Novartis Investigative Site
Berlin, 12200
Novartis Investigative Site
Cologne, 50924
United Kingdom2 sites
Novartis Investigative Site
Leicester, LE1 5WW
Novartis Investigative Site
London, EC1A 7BE
About this study
Official 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)
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.
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma
- Being tested
- HCD122
- Keywords
- HCD122, CD40, NHL, HL
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCD122Drug
| Study group | Role | What they receive |
|---|---|---|
| HCD122 | Other | Not described Receives: Drug: HCD122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints (phase I) - Incidence rate of DLT and AE
Measured: 2 years
Primary endpoint (phase II) - Response rate
Measured: 2 years
Secondary outcomes (1)
Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- XOMA (US) LLC
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmaceuticlas, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670592
- Sponsor's protocol ID
- CHCD122A2103
- Other IDs
- 2007-004888-22
- Status last verified
- Jan 2014
- First submitted
- 30 Apr 2008
- Last updated
- 17 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00670592
- Acronym / sponsor ID
- CHCD122A2103
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma
- Keywords
- HCD122, CD40, NHL, HL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- XOMA (US) LLC
- Study start
- Mar 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCD122 | Other | Drug: HCD122 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCD122 | Drug | HCD122 |
Primary outcome
Primary endpoints (phase I) - Incidence rate of DLT and AE
Time frame: 2 years
Primary endpoint (phase II) - Response rate
Time frame: 2 years
1 secondary outcome
Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Results for CHCD122A2103 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Novartis Pharmaceuticlas study director
Novartis Pharmaceuticals
28 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HCD122 in people with Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma, run by Novartis Pharmaceuticals at 28 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France, United States, Belgium, Italy, Australia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints (phase I) - Incidence rate of DLT and AE (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.