ClinicalTrials.gg
Sign In
TerminatedNCT01440179MYRALLUpdated Sep 21, 2022

SAR3419 in Acute Lymphoblastic Leukemia

A Phase 2 interventional study of SAR3419 in Acute Lymphocytic Leukaemia, sponsored by Sanofi. Terminated at 11 sites in 2 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Why this study was terminated
The study is stopped due to very modest activity compared to competitors
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
16 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Acute Lymphocytic Leukaemia
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.

This study's enrollment of 100 is above the median of 40 across 1,691 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

Browse Sanofi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

None

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    SAR3419

    Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles.

    Drug: SAR3419

Interventions

  • DrugSAR3419

    Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous

06

What researchers measure

Primary outcomes

  1. Number of participants achieving an Objective Response Rate

    Time frame: 4 to 8 weeks

Secondary outcomes

  1. Number of participants with Adverse Events

    Time frame: Up to 1 year

  2. Assessment of PK parameter - maximum concentration (Cmax)

    Time frame: Up to 8 months

  3. Assessment of PK parameter - area under curve (AUC)

    Time frame: Up to 8 months

  4. Assessment of PK parameter - half-life (T1/2)

    Time frame: Up to 8 months

  5. Assessment of PK parameter - clearance

    Time frame: Up to 8 months

  6. Assessment of PK parameter - volume in steady state (Vss)

    Time frame: Up to 8 months

  7. Assessment of minimal residual disease (MRD)

    Time frame: 4 to 8 weeks

07

Study locations

11 sites
  • Investigational Site Number 840006
    Denver, Colorado 80218, United States
  • Investigational Site Number 840003
    Nashville, Tennessee 37203, United States
  • Investigational Site Number 840001
    Houston, Texas 77030, United States
  • Investigational Site Number 840002
    San Antonio, Texas 78229, United States
  • Investigational Site Number 840004
    Milwaukee, Wisconsin 53226, United States
  • Investigational Site Number 250006
    Amiens, 80054, France
  • Investigational Site Number 250001
    Paris, 75475, France
  • Investigational Site Number 250002
    Pessac, 33600, France
  • Investigational Site Number 250008
    Pierre-Bénite, 69310, France
  • Investigational Site Number 250004
    Rennes, 35033, France
  • Investigational Site Number 250005
    Strasbourg, 67200, France
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2011, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2011
First posted
Sep 26, 2011
Start
Oct 2011
Primary completionActual
May 2014
CompletionActual
May 2014
Results delay requested
Sep 8, 2022
Last update
Sep 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01440179
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Sep 26, 2011
Start date
Oct 2011
Primary completion
May 2014
Completion
May 2014
Last update
Sep 21, 2022

Study contacts

Clinical Sciences & Operations
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Coltuximab ravtansine

Other studies in this condition

Precursor Cell Lymphoblastic Leukemia-Lymphoma →

Other studies from this sponsor

Sanofi →

Start the discussion