SAR3419 in Acute Lymphoblastic Leukemia (MYRALL)

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

Study Overview

• Status: Terminated
• Conditions: Acute Lymphocytic Leukaemia
• Intervention / Treatment: Drug: SAR3419

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

None

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants achieving an Objective Response Rate	4 to 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Adverse Events	Up to 1 year
Assessment of PK parameter - maximum concentration (Cmax)	Up to 8 months
Assessment of PK parameter - area under curve (AUC)	Up to 8 months
Assessment of PK parameter - half-life (T1/2)	Up to 8 months
Assessment of PK parameter - clearance	Up to 8 months
Assessment of PK parameter - volume in steady state (Vss)	Up to 8 months
Assessment of minimal residual disease (MRD)	4 to 8 weeks

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General 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. Erratum In: Clin Cancer Res. 2013 Jun 1;19(11):3108.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: September 22, 2011
• First Posted (Estimate): September 26, 2011

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: EFC11603; U1111-1118-0642 (Other Identifier: UTN); 2012-002961-36 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No