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SAR3419 in Acute Lymphoblastic Leukemia (MYRALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01440179
Recruitment Status : Terminated (The study is stopped due to very modest activity compared to competitors)
First Posted : September 26, 2011
Last Update Posted : August 27, 2014
Information provided by (Responsible Party):

Brief Summary:

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objectives:

  • Response duration
  • Progression Free Survival
  • Minimal residual disease
  • Safety
  • Pharmacokinetics

Condition or disease Intervention/treatment Phase
Acute Lymphocytic Leukaemia Drug: SAR3419 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: SAR3419
Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles.
Drug: SAR3419
Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous

Primary Outcome Measures :
  1. Number of participants achieving an Objective Response Rate [ Time Frame: 4 to 8 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01440179

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United States, Colorado
Investigational Site Number 840006
Denver, Colorado, United States, 80218
United States, Tennessee
Investigational Site Number 840003
Nashville, Tennessee, United States, 37203
United States, Texas
Investigational Site Number 840001
Houston, Texas, United States, 77030
Investigational Site Number 840002
San Antonio, Texas, United States, 78229
United States, Wisconsin
Investigational Site Number 840004
Milwaukee, Wisconsin, United States, 53226
Investigational Site Number 250006
Amiens, France, 80054
Investigational Site Number 250001
Paris Cedex 10, France, 75475
Investigational Site Number 250002
Pessac, France, 33600
Investigational Site Number 250008
Pierre Benite, France, 69310
Investigational Site Number 250004
Rennes, France, 35033
Investigational Site Number 250005
Strasbourg, France, 67200
Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanofi Identifier: NCT01440179     History of Changes
Other Study ID Numbers: EFC11603
U1111-1118-0642 ( Other Identifier: UTN )
2012-002961-36 ( EudraCT Number )
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
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Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action