LymphomaPhase 1NCT00796731
SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma
A Phase 1 study testing SAR3419 in people with Lymphoma and Non-Hodgkin, run by Sanofi at 6 sites in France.
Trial summary
The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- SAR3419
- Type of treatment
- Injection or infusion
- How many people
- 77 participants
- Where
- 6 sitesFrance
- Study dates
- Oct 2008to Jun 2012
- 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
- Diagnosis of B-cell non Hodgkin's lymphoma
- Relapsed or refractory after standard treatments and with no curative option with conventional therapy (Patients having undergone stem cell transplantation may be included)
- CD19 positive disease by flow cytometry or immunohistochemistry
Who cannot join
- Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
- Evidence of cerebral or meningeal involvement by lymphoma
- Patients without bi-dimensionally measurable disease
- ECOG performance status > 2
- Life expectancy less than 3 months
- Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
Show all 14Show fewer
- Previous radioimmunotherapy within 12 weeks
- Known anaphylaxis to infused proteins
- HIV, HBV and HCV positivity
- Poor kidney, liver and bone marrow functions
- Any serious active disease or co-morbid condition, which, in the opinion of the principle investigator, will interfere with the safety or the compliance with the study
- Pregnant or breast-feeding women
- Patients with reproductive potential without effective birth control methods
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Sanofi-Aventis Investigational Site Number 250004
Créteil, 94010
Sanofi-Aventis Investigational Site Number 250006
Lille, 59037
Sanofi-Aventis Investigational Site Number 250001
Pierre-Bénite, 69495
Sanofi-Aventis Investigational Site Number 250005
Rennes, 35033
Sanofi-Aventis Investigational Site Number 250003
Rouen, 76038
Sanofi-Aventis Investigational Site Number 250002
Villejuif, 94805
About this study
Official title: A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma (NHL)
The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly.
Secondary objectives are:
- to characterize the global safety profile
- to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule
- to assess preliminary evidence of anti-lymphoma activity.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- SAR3419
- Keywords
- B-cell lymphoma, NHL
- Medical subject headings
- Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR3419Drug
administered by intravenous infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT(s) at each dose level
Measured: during the initial 3-week period of treatment
Secondary outcomes (4)
Cumulative DLT(s)
Measured: over the entire period of treatment
Incidence of Adverse Events and laboratory abnormalities
Measured: study period
Tumor response (complete response, partial response) and duration of the response
Measured: study period
Pharmacokinetics parameters
Measured: Study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bertrand COIFFIER, Professor of Hematology, Principal investigator, Centre Hospitalier Lyon Sud, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796731
- Sponsor's protocol ID
- TED6829
- Other IDs
- EudraCT 2007-004868-41
- Status last verified
- Jul 2012
- First submitted
- 21 Nov 2008
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT00796731
- Acronym / sponsor ID
- TED6829
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- B-cell lymphoma, NHL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Nov 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.
The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly.
Secondary objectives are:
- to characterize the global safety profile
- to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule
- to assess preliminary evidence of anti-lymphoma activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of B-cell non Hodgkin's lymphoma
- Relapsed or refractory after standard treatments and with no curative option with conventional therapy (Patients having undergone stem cell transplantation may be included)
- CD19 positive disease by flow cytometry or immunohistochemistry
Key exclusion criteria (14 listed)
- Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
- Evidence of cerebral or meningeal involvement by lymphoma
- Patients without bi-dimensionally measurable disease
- ECOG performance status > 2
- Life expectancy less than 3 months
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 |
|---|---|---|
| SAR3419administered by intravenous infusion | Drug | – |
Primary outcome
Incidence of DLT(s) at each dose level
Time frame: during the initial 3-week period of treatment
4 secondary outcomes
Cumulative DLT(s)
Time frame: over the entire period of treatment
Incidence of Adverse Events and laboratory abnormalities
Time frame: study period
Tumor response (complete response, partial response) and duration of the response
Time frame: study period
Pharmacokinetics parameters
Time frame: Study period
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 Jul 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.
Bertrand COIFFIER, Professor of Hematology principal investigator
Centre Hospitalier Lyon Sud, France
6 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 SAR3419 in people with Lymphoma and Non-Hodgkin, run by Sanofi at 6 sites in France.
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 3 inclusion and 14 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 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 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?
Incidence of DLT(s) at each dose level (time frame: during the initial 3-week period of treatment). 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 Jul 2012.