Diffuse Large B-cell LymphomaPhase 2STARLYTENCT01472887
SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients
A Phase 2 study testing SAR3419 in people with Diffuse Large B-cell Lymphoma, run by Sanofi at 28 sites in 9 countries.
Trial summary
Primary Objective: Participants achieving an Objective Response Rate Secondary Objective: Progression Free Survival Overall Survival Response Duration Safety 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 28 sitesin 9 countries
- Study dates
- Jan 2012to Sep 2016
- 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 (de novo or transformed) expressing CD19 by immunohistochemistry or flow cytometry analysis (>30% positivity), based on recent (less than 6 months) or new biopsy.
- At least 1 prior specific therapeutic regimen, one of which should have included rituximab (patients previously eligible for transplantation: the salvage treatment followed by intensification and Autologous Stem Cell Transplant (ASCT) will be considered one regimen).
- Relapsed disease after standard 1st line therapy for aggressive lymphoma - not eligible for high dose chemotherapy with stem cell support. Relapsed or refractory disease after two lines of therapy one of which could have included Autologous Stem Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease free interval of at least 6 months after completion of last therapy. Refractory is defined as progression of disease during prior therapy or within 6 months from its completion.
- Available paraffin-embedded tissue should have been collected no longer than 6 months prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If archival material is not available, a Fine Needle Aspiration (FNA) must be obtained.
Who cannot join
- Primary refractory patients
- Patients with primary mediastinal DLBCL
- 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
28 sites in 9 countries.
28 sites in 9 countries
Italy7 sites
Investigational Site Number 380002
Bergamo, 24127
Investigational Site Number 380004
Bologna, 40138
Investigational Site Number 380008
Mestre, 30174
Investigational Site Number 380001
Milan, 20133
Investigational Site Number 380007
Modena, 41100
Investigational Site Number 380003
Palermo, 90145
Investigational Site Number 380006
Pavia, 27100
Spain4 sites
Investigational Site Number 724002
Barcelona, 08003
Investigational Site Number 724004
Barcelona, 08035
Investigational Site Number 724001
Madrid, 28046
Investigational Site Number 724003
Valencia, 46010
United States3 sites
Investigational Site Number 840003
Augusta, Georgia, 30912
Investigational Site Number 840005
Boise, Idaho, 83712
Investigational Site Number 840001
Denver, Colorado, 80262
Czechia3 sites
Investigational Site Number 203002
Brno, 62500
Investigational Site Number 203003
Prague, 10034
Investigational Site Number 203001
Prague, 12808
Poland3 sites
Investigational Site Number 616003
Brzozów, 36-200
Investigational Site Number 616002
Kielce, 25-734
Investigational Site Number 616001
Warsaw, 04-141
Belgium2 sites
Investigational Site Number 056002
Ghent, 9000
Investigational Site Number 056001
Leuven, 3000
Israel2 sites
Investigational Site Number 376003
Jerusalem, 91120
Investigational Site Number 376002
Tel Litwinsky, 52621
Turkey (Türkiye)2 sites
Investigational Site Number 792003
Izmir, 35040
Investigational Site Number 792001
Izmir, 35340
United Kingdom2 sites
Investigational Site Number 826001
Leicester
Investigational Site Number 826002
Manchester, M20 4BX
About this study
Official title: An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma
Primary Objective:
Participants achieving an Objective Response Rate
Secondary Objective:
- Progression Free Survival
- Overall Survival
- Response Duration
- Safety
Read the detailed description
The screening period = up to 4 weeks prior to SAR3419 administration
The treatment period = from the day of first administration of SAR3419 until the End-Of-Treatment visit. All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity or other reasons for therapy discontinuation - After therapy discontinuation all patients will enter a safety follow-up period of 42 days starting from the day of administration of the last dose of SAR3419 and ending with the End Of Treatment visit.
All patients, regardless whether they have progressed or not, will be followed until death or end of study to evaluate survival for at least 18 months.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- SAR3419
- 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:concentrate for solution for infusion
Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR3419 | Experimental | All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation Receives: Drug: SAR3419 |
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 months
Secondary outcomes (4)
Number of participants with Adverse Events
Measured: Up to 1 year
Response duration - Time
Measured: Up to 18 months after the first infusion of the last patient
Progression Free Survival - Time
Measured: Up to 18 months after the first infusion of the last patient
Overall Survival - Time
Measured: Up to 18 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 posted17 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 61 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
- NCT01472887
- Sponsor's protocol ID
- ARD10248
- Other IDs
- 2011-003657-26, U1111-1115-3349
- Acronym
- STARLYTE
- Status last verified
- Jan 2018
- First submitted
- 14 Nov 2011
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Trneny M, Verhoef G, Dyer MJ, Ben Yehuda D, Patti C, Canales M, Lopez A, Awan FT, Montgomery PG, Janikova A, Barbui AM, Sulek K, Terol MJ, Radford J, Guidetti A, Di Nicola M, Siraudin L, Hatteville L, Schwab S, Oprea C, Gianni AM. A phase II multicenter study of the anti-CD19 antibody drug conjugate coltuximab ravtansine (SAR3419) in patients with relapsed or refractory diffuse large B-cell lymphoma previously treated with rituximab-based immunotherapy. Haematologica. 2018 Aug;103(8):1351-1358. doi: 10.3324/haematol.2017.168401. Epub 2018 May 10.
PubMed 29748443
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01472887
- Acronym / sponsor ID
- STARLYTE / ARD10248
- Conditions
- Diffuse Large B-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 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
Secondary Objective:
- Progression Free Survival
- Overall Survival
- Response Duration
- Safety
Detailed description
The screening period = up to 4 weeks prior to SAR3419 administration
The treatment period = from the day of first administration of SAR3419 until the End-Of-Treatment visit. All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity or other reasons for therapy discontinuation - After therapy discontinuation all patients will enter a safety follow-up period of 42 days starting from the day of administration of the last dose of SAR3419 and ending with the End Of Treatment visit.
All patients, regardless whether they have progressed or not, will be followed until death or end of study to evaluate survival for at least 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR3419 | Experimental | Drug: SAR3419All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) expressing CD19 by immunohistochemistry or flow cytometry analysis (>30% positivity), based on recent (less than 6 months) or new biopsy.
- At least 1 prior specific therapeutic regimen, one of which should have included rituximab (patients previously eligible for transplantation: the salvage treatment followed by intensification and Autologous Stem Cell Transplant (ASCT) will be considered one regimen).
- Relapsed disease after standard 1st line therapy for aggressive lymphoma - not eligible for high dose chemotherapy with stem cell support. Relapsed or refractory disease after two lines of therapy one of which could have included Autologous Stem Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease free interval of at least 6 months after completion of last therapy. Refractory is defined as progression of disease during prior therapy or within 6 months from its completion.
- Available paraffin-embedded tissue should have been collected no longer than 6 months prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If archival material is not available, a Fine Needle Aspiration (FNA) must be obtained.
Key exclusion criteria (3 listed)
- Primary refractory patients
- Patients with primary mediastinal DLBCL
- 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:concentrate for solution for infusion Route of administration: intravenous | Drug | SAR3419 |
Primary outcome
Number of participants achieving an Objective Response Rate
Time frame: 18 months
4 secondary outcomes
Number of participants with Adverse Events
Time frame: Up to 1 year
Response duration - Time
Time frame: Up to 18 months after the first infusion of the last patient
Progression Free Survival - Time
Time frame: Up to 18 months after the first infusion of the last patient
Overall Survival - Time
Time frame: Up to 18 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 25 Jan 2018.
- Derived from this study: PubMed 29748443Trneny M, Verhoef G, Dyer MJ, Ben Yehuda D, Patti C, Canales M, Lopez A, Awan FT, Montgomery PG, Janikova A, Barbui AM, Sulek K, Terol MJ, Radford J, Guidetti A, Di Nicola M, Siraudin L, Hatteville L, Schwab S, Oprea C, Gianni AM. A phase II multicenter study of the anti-CD19 antibody drug conjugate coltuximab ravtansine (SAR3419) in patients with relapsed or refractory diffuse large B-cell lymphoma previously treated with rituximab-based immunotherapy. Haematologica. 2018 Aug;103(8):1351-1358. doi: 10.3324/haematol.2017.168401. Epub 2018 May 10.
Related trials for Diffuse Large B-cell Lymphoma
Not yet recruitingPhase 1
A Multicenter, Phase I Study to Evaluate the Feasibility and Safety of Autologous Cytokine-Induced Killer Cells (CIK_D332) in Combination With Tafasitamab and Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma (DLBCL)
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Enrolling by invitationObservational study
Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing
Leukemia, Lymphoma
Active, not recruitingPhase 1
Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma
Active, not recruitingPhase 1/2
Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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
28 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR3419 in people with Diffuse Large B-cell Lymphoma, run by Sanofi at 28 sites in 9 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 4 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: finished, as of the sponsor's last update on 25 Jan 2018. 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 Italy, Spain, United States, Czechia, Poland and 4 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 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 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01472887, which also lists 1 linked publication.
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 25 Jan 2018; AzTrials last refreshed its copy on 30 Oct 2026.