Acute Lymphocytic LeukaemiaPhase 2MYRALLNCT01440179
SAR3419 in Acute Lymphoblastic Leukemia
A Phase 2 study testing SAR3419 in people with Acute Lymphocytic Leukaemia, run by Sanofi at 11 sites in 2 countries.
Trial summary
Primary Objective: Participants achieving an Objective Response Rate Secondary Objectives: Response duration Progression Free Survival Minimal residual disease Safety Pharmacokinetics Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Lymphocytic Leukaemia
- 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
- 100 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Oct 2011to May 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previously treated Acute Lymphoblastic Leukemia of B cell origin (including Burkitt's lymphoma) in relapse or primary refractory. Patients in first relapse will be eligible regardless of the first remission duration.
- No more than 3 prior salvage therapies.
- Philadelphia positive patients failing treatment with imatinib mesylate are accepted.
- CD19 positive patients.
Who cannot join
- None
- 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
11 sites in 2 countries.
11 sites in 2 countries
France6 sites
Investigational Site Number 250006
Amiens, 80054
Investigational Site Number 250001
Paris, 75475
Investigational Site Number 250002
Pessac, 33600
Investigational Site Number 250008
Pierre-Bénite, 69310
Investigational Site Number 250004
Rennes, 35033
Investigational Site Number 250005
Strasbourg, 67200
United States5 sites
Investigational Site Number 840006
Denver, Colorado, 80218
Investigational Site Number 840001
Houston, Texas, 77030
Investigational Site Number 840004
Milwaukee, Wisconsin, 53226
Investigational Site Number 840003
Nashville, Tennessee, 37203
Investigational Site Number 840002
San Antonio, Texas, 78229
About this study
Official title: Phase II Two Stage Finding Run-in Study of SAR3419, An Anti-CD19 Antibody-Maytansine Conjugate, Administered as a Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Primary Objective:
Participants achieving an Objective Response Rate
Secondary Objectives:
- Response duration
- Progression Free Survival
- Minimal residual disease
- Safety
- Pharmacokinetics
Read the detailed description
The duration of the study for an individual patient will include:
- The screening period = up to 4 weeks prior to the first administration of SAR3419.
- The treatment period:
- Induction period = 4 to 8 weeks
- Maintenance = up to a total maintenance treatment of 6 months
- A safety follow-up period of 42 days after the last dose.
- Any patient who discontinues the study treatment without disease progression will be followed every 2 months until disease progression, initiation of a new anti-cancer therapy, death or end-of-study date, whatever comes first.
- Conditions
- Acute Lymphocytic Leukaemia
- Being tested
- SAR3419
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR3419Drug
Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR3419 | Experimental | Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles. 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: 4 to 8 weeks
Secondary outcomes (7)
Number of participants with Adverse Events
Measured: Up to 1 year
Assessment of PK parameter - maximum concentration (Cmax)
Measured: Up to 8 months
Assessment of PK parameter - area under curve (AUC)
Measured: Up to 8 months
Assessment of PK parameter - half-life (T1/2)
Measured: Up to 8 months
Assessment of PK parameter - clearance
Measured: Up to 8 months
Assessment of PK parameter - volume in steady state (Vss)
Measured: Up to 8 months
Assessment of minimal residual disease (MRD)
Measured: 4 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: The study is stopped due to very modest activity compared to competitors
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 Acute Lymphocytic LeukaemiaStudies 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
- 100 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
- NCT01440179
- Sponsor's protocol ID
- EFC11603
- Other IDs
- U1111-1118-0642, 2012-002961-36
- Acronym
- MYRALL
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2011
- Last updated
- 21 Sep 2022
- Results posted
- No
Publications
Carol H, Szymanska B, Evans K, Boehm I, Houghton PJ, Smith MA, Lock RB. The anti-CD19 antibody-drug conjugate SAR3419 prevents hematolymphoid relapse postinduction therapy in preclinical models of pediatric acute lymphoblastic leukemia. Clin Cancer Res. 2013 Apr 1;19(7):1795-805. doi: 10.1158/1078-0432.CCR-12-3613. Epub 2013 Feb 20.
PubMed 23426279
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Two Stage Finding Run-in Study of SAR3419, An Anti-CD19 Antibody-Maytansine Conjugate, Administered as a Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT01440179
- Acronym / sponsor ID
- MYRALL / EFC11603
- Conditions
- Acute Lymphocytic Leukaemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is stopped due to very modest activity compared to competitors
- Enrolment
- 100 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Sep 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 Objectives:
- Response duration
- Progression Free Survival
- Minimal residual disease
- Safety
- Pharmacokinetics
Detailed description
The duration of the study for an individual patient will include:
- The screening period = up to 4 weeks prior to the first administration of SAR3419.
- The treatment period:
- Induction period = 4 to 8 weeks
- Maintenance = up to a total maintenance treatment of 6 months
- A safety follow-up period of 42 days after the last dose.
- Any patient who discontinues the study treatment without disease progression will be followed every 2 months until disease progression, initiation of a new anti-cancer therapy, death or end-of-study date, whatever comes first.
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: SAR3419Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Previously treated Acute Lymphoblastic Leukemia of B cell origin (including Burkitt's lymphoma) in relapse or primary refractory. Patients in first relapse will be eligible regardless of the first remission duration.
- No more than 3 prior salvage therapies.
- Philadelphia positive patients failing treatment with imatinib mesylate are accepted.
- CD19 positive patients.
Key exclusion criteria (2 listed)
- None
- 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 solution for infusion Route of administration: intravenous | Drug | SAR3419 |
Primary outcome
Number of participants achieving an Objective Response Rate
Time frame: 4 to 8 weeks
7 secondary outcomes
Number of participants with Adverse Events
Time frame: Up to 1 year
Assessment of PK parameter - maximum concentration (Cmax)
Time frame: Up to 8 months
Assessment of PK parameter - area under curve (AUC)
Time frame: Up to 8 months
Assessment of PK parameter - half-life (T1/2)
Time frame: Up to 8 months
Assessment of PK parameter - clearance
Time frame: Up to 8 months
Assessment of PK parameter - volume in steady state (Vss)
Time frame: Up to 8 months
Assessment of minimal residual disease (MRD)
Time frame: 4 to 8 weeks
Results and safety
The study was stopped early (reason given: The study is stopped due to very modest activity compared to competitors). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 23426279Carol H, Szymanska B, Evans K, Boehm I, Houghton PJ, Smith MA, Lock RB. The anti-CD19 antibody-drug conjugate SAR3419 prevents hematolymphoid relapse postinduction therapy in preclinical models of pediatric acute lymphoblastic leukemia. Clin Cancer Res. 2013 Apr 1;19(7):1795-805. doi: 10.1158/1078-0432.CCR-12-3613. Epub 2013 Feb 20.
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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
11 sites in 2 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 Acute Lymphocytic Leukaemia, run by Sanofi at 11 sites in 2 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 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: stopped early, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, 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 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 was stopped early (reason given: The study is stopped due to very modest activity compared to competitors). 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?
Number of participants achieving an Objective Response Rate (time frame: 4 to 8 weeks). 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 NCT01440179, 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 21 Sep 2022.