Chronic Lymphocytic LeukemiaPhase 1NCT00108108
Dose-finding Trial of HCD122 in Patients With Chronic Lymphocytic Leukemia (CLL) That is Relapsed or Non-responsive to Prior Fludaribine Therapy
A Phase 1 study testing HCD122 in people with Chronic Lymphocytic Leukemia, run by Novartis Pharmaceuticals at 5 sites in United States.
Trial summary
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- HCD122
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2005to Jun 2008
- Phase
- Phase 1
- 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
- Clinical diagnosis of CLL requiring treatment
- Refractory or relapsed disease
- Prior treatment with fludarabine
- Male or Female
- >18 years of age
Who cannot join
- Treatment with rituximab within 90 days and alemtuzumab or any monoclonal antibody within 6 months.
- Clinically significant cardiac dysfunction or other significant organ dysfunction
- Additional eligibility criteria apply that will be reviewed with potential study subjects at the site.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies
Baltimore, Maryland, 21231
St. Francis Cancer Research Foundation
Beech Grove, Indiana, 46107
OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101
Columbus, Ohio, 43210
MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent
Houston, Texas, 77030-4009
University of California San Diego StudyCoordinator:CHCD122A2101
La Jolla, California, 92093-0658
About this study
Official title: An Open-label,Multi-center, Phase l/ll Study of Anti-CD40 Monoclonal Antibody (HCD122) Administered Intravenously to Subjects With Advanced Chronic Lymphocytic Leukemia That is Refractory or Relapsed After at Least One Previous Fludarabine-containing Chemotherapy Regimen
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- HCD122
- Keywords
- Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Lymphoid
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 | Experimental | Not described Receives: Drug: HCD122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the maximum tolerated dose (MTD)
Measured: between study Day 1 and study Day 50
Secondary outcomes (4)
to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients
Measured: between study Day 1 and study termination
To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients
Measured: between study Day 1 and study termination
To characterize peripheral blood CD40 occupancy on CD5/CD19 (CLL) cells and CD5/CD19 cell depletion activity (pharmacodynamics) of HCD122 at each dose level in dose escalation patients
Measured: between study Day 1 and study termination
To assess preliminary anti-tumor activity of HCD122 in dose escalation patients
Measured: between study Day 1 and study termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2005 (estimated)
- Study startApr 2005
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Slow enrollment and minimal preliminary biological and clinical efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 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, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108108
- Sponsor's protocol ID
- CHCD122A2101
- Status last verified
- Sep 2012
- First submitted
- 14 Apr 2005
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label,Multi-center, Phase l/ll Study of Anti-CD40 Monoclonal Antibody (HCD122) Administered Intravenously to Subjects With Advanced Chronic Lymphocytic Leukemia That is Refractory or Relapsed After at Least One Previous Fludarabine-containing Chemotherapy Regimen
- ClinicalTrials.gov ID
- NCT00108108
- Acronym / sponsor ID
- CHCD122A2101
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Lymphocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and minimal preliminary biological and clinical efficacy.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- XOMA (US) LLC
- Study start
- Apr 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Apr 2005 (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.
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCD122 | Experimental | Drug: HCD122 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of CLL requiring treatment
- Refractory or relapsed disease
- Prior treatment with fludarabine
- Male or Female
- >18 years of age
Key exclusion criteria (3 listed)
- Treatment with rituximab within 90 days and alemtuzumab or any monoclonal antibody within 6 months.
- Clinically significant cardiac dysfunction or other significant organ dysfunction
- Additional eligibility criteria apply that will be reviewed with potential study subjects at the site.
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
to determine the maximum tolerated dose (MTD)
Time frame: between study Day 1 and study Day 50
4 secondary outcomes
to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients
Time frame: between study Day 1 and study termination
To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients
Time frame: between study Day 1 and study termination
To characterize peripheral blood CD40 occupancy on CD5/CD19 (CLL) cells and CD5/CD19 cell depletion activity (pharmacodynamics) of HCD122 at each dose level in dose escalation patients
Time frame: between study Day 1 and study termination
To assess preliminary anti-tumor activity of HCD122 in dose escalation patients
Time frame: between study Day 1 and study termination
Results and safety
The study was stopped early (reason given: Slow enrollment and minimal preliminary biological and clinical efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2012.
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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 study chair
Novartis
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HCD122 in people with Chronic Lymphocytic Leukemia, run by Novartis Pharmaceuticals at 5 sites in United States.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 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.
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 was stopped early (reason given: Slow enrollment and minimal preliminary biological and clinical efficacy.). Results are not available in the source record.
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?
to determine the maximum tolerated dose (MTD) (time frame: between study Day 1 and study Day 50). 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 1 Oct 2012.