Diffuse Large B-Cell LymphomaPhase 2NCT01470456
Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Phase 2 study testing SAR3419 and rituximab in people with Diffuse Large B-Cell Lymphoma, run by Sanofi at 13 sites in 3 countries.
Trial summary
Primary Objective: Participants Achieving an Objective Response Rate (Cheson 2007) Secondary Objectives: Progression Free Survival Overall Survival Response Duration Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- SAR3419 and rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Nov 2011to Sep 2014
- Phase
- Phase 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
- Histological diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL)
- Relapsed or refractory after at least one standard treatment including rituximab
- CD19 and CD20 positive disease
Who cannot join
- No bi-dimensionally measurable lesion by CT scan (defined as presence of at least one tumor mass measuring >1.5 x 1.5 cm)
- 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
13 sites in 3 countries.
13 sites in 3 countries
France11 sites
Investigational Site Number 250004
Créteil, 94010
Investigational Site Number 250009
Dijon, 21000
Investigational Site Number 250006
Lille, 59037
Investigational Site Number 250011
Marseille, 13273
Investigational Site Number 250010
Montpellier, 34295
Investigational Site Number 250008
Nantes, 44093
Investigational Site Number 250007
Paris, 75475
Investigational Site Number 250001
Pierre-Bénite, 69495
Investigational Site Number 250005
Rennes, 35033
Investigational Site Number 250003
Rouen, 76038
Investigational Site Number 250002
Villejuif, 94805
About this study
Official title: An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas
Primary Objective:
Participants Achieving an Objective Response Rate (Cheson 2007)
Secondary Objectives:
- Progression Free Survival
- Overall Survival
- Response Duration
Read the detailed description
- The screening period = up to 4 weeks prior to the first administration of combined therapy
- The treatment period = 3 months of combined therapy. A safety follow-up of 42 to 49 days after the last dose of treatment is planned for all patients.
- The follow-up period: Patients who are not progressing at the end of study treatment will be followed until progression or initiation of another anti-lymphoma therapy. All patients will be followed for two years to evaluate survival.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- SAR3419, rituximab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR3419Drug
Pharmaceutical form:solution for infusion Route of administration: Intravenous
rituximabDrug
Pharmaceutical form:solution for infusion Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR3419 + Rituximab | Experimental | Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent. Receives: Drug: SAR3419; Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants achieving an Objective Response Rate
Measured: 18 weeks
Secondary outcomes (4)
Number of participants with Adverse Events
Measured: Up to 6 months
Response Duration -Time
Measured: Up to 24 months after the first infusion of the last patient
Progression Free Survival -Time
Measured: Up to 24 months after the first infusion of the last patient
Overall survival -Time
Measured: Up to 24 months after the first infusion of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470456
- Sponsor's protocol ID
- TCD12333
- Other IDs
- 2011-002865-39, U1111-1120-0315
- Status last verified
- Nov 2014
- First submitted
- 9 Nov 2011
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT01470456
- Acronym / sponsor ID
- TCD12333
- Conditions
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Nov 2011 (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.
Primary Objective:
Participants Achieving an Objective Response Rate (Cheson 2007)
Secondary Objectives:
- Progression Free Survival
- Overall Survival
- Response Duration
Detailed description
- The screening period = up to 4 weeks prior to the first administration of combined therapy
- The treatment period = 3 months of combined therapy. A safety follow-up of 42 to 49 days after the last dose of treatment is planned for all patients.
- The follow-up period: Patients who are not progressing at the end of study treatment will be followed until progression or initiation of another anti-lymphoma therapy. All patients will be followed for two years to evaluate survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR3419 + Rituximab | Experimental | Drug: SAR3419, Drug: rituximabCombined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histological diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL)
- Relapsed or refractory after at least one standard treatment including rituximab
- CD19 and CD20 positive disease
Key exclusion criteria (2 listed)
- No bi-dimensionally measurable lesion by CT scan (defined as presence of at least one tumor mass measuring >1.5 x 1.5 cm)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| SAR3419Pharmaceutical form:solution for infusion Route of administration: Intravenous | Drug | SAR3419 + Rituximab |
| rituximabPharmaceutical form:solution for infusion Route of administration: intravenous | Drug | SAR3419 + Rituximab |
Primary outcome
Number of participants achieving an Objective Response Rate
Time frame: 18 weeks
4 secondary outcomes
Number of participants with Adverse Events
Time frame: Up to 6 months
Response Duration -Time
Time frame: Up to 24 months after the first infusion of the last patient
Progression Free Survival -Time
Time frame: Up to 24 months after the first infusion of the last patient
Overall survival -Time
Time frame: Up to 24 months after the first infusion of the last patient
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 13 Nov 2014.
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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.
Clinical Sciences & Operations study director
Sanofi
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR3419 and rituximab in people with Diffuse Large B-Cell Lymphoma, run by Sanofi at 13 sites in 3 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 3 inclusion and 2 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 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Austria, Norway. 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 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?
Number of participants achieving an Objective Response Rate (time frame: 18 weeks). 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 13 Nov 2014.