SAR3419 in Acute Lymphoblastic Leukemia (MYRALL)

This study has been terminated.
(The study is stopped due to very modest activity compared to competitors)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01440179
First received: September 21, 2011
Last updated: August 26, 2014
Last verified: May 2014
  Purpose

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objectives:

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

Condition Intervention Phase
Acute Lymphocytic Leukaemia
Drug: SAR3419
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of participants achieving an Objective Response Rate [ Time Frame: 4 to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Assessment of PK parameter - maximum concentration (Cmax) [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - area under curve (AUC) [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - half-life (T1/2) [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - clearance [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - volume in steady state (Vss) [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
  • Assessment of minimal residual disease (MRD) [ Time Frame: 4 to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440179

Locations
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
France
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
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01440179     History of Changes
Other Study ID Numbers: EFC11603, U1111-1118-0642, 2012-002961-36
Study First Received: September 21, 2011
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014