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SAR3419 in Acute Lymphoblastic Leukemia (MYRALL)

Primary Purpose

Acute Lymphocytic Leukaemia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SAR3419
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphocytic Leukaemia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840006
  • Investigational Site Number 840003
  • Investigational Site Number 840001
  • Investigational Site Number 840002
  • Investigational Site Number 840004
  • Investigational Site Number 250006
  • Investigational Site Number 250001
  • Investigational Site Number 250002
  • Investigational Site Number 250008
  • Investigational Site Number 250004
  • Investigational Site Number 250005

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SAR3419

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants achieving an Objective Response Rate

Secondary Outcome Measures

Number of participants with Adverse Events
Assessment of PK parameter - maximum concentration (Cmax)
Assessment of PK parameter - area under curve (AUC)
Assessment of PK parameter - half-life (T1/2)
Assessment of PK parameter - clearance
Assessment of PK parameter - volume in steady state (Vss)
Assessment of minimal residual disease (MRD)

Full Information

First Posted
September 21, 2011
Last Updated
September 15, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01440179
Brief Title
SAR3419 in Acute Lymphoblastic Leukemia
Acronym
MYRALL
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 Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
The study is stopped due to very modest activity compared to competitors
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphocytic Leukaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAR3419
Arm Type
Experimental
Arm Description
Administered for one to two induction cycles, followed by maintenance cycles up to 6 cycles.
Intervention Type
Drug
Intervention Name(s)
SAR3419
Intervention Description
Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous
Primary Outcome Measure Information:
Title
Number of participants achieving an Objective Response Rate
Time Frame
4 to 8 weeks
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events
Time Frame
Up to 1 year
Title
Assessment of PK parameter - maximum concentration (Cmax)
Time Frame
Up to 8 months
Title
Assessment of PK parameter - area under curve (AUC)
Time Frame
Up to 8 months
Title
Assessment of PK parameter - half-life (T1/2)
Time Frame
Up to 8 months
Title
Assessment of PK parameter - clearance
Time Frame
Up to 8 months
Title
Assessment of PK parameter - volume in steady state (Vss)
Time Frame
Up to 8 months
Title
Assessment of minimal residual disease (MRD)
Time Frame
4 to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840006
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Investigational Site Number 840003
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Investigational Site Number 840001
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number 840002
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site Number 840004
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Investigational Site Number 250006
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Investigational Site Number 250001
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Investigational Site Number 250002
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Investigational Site Number 250008
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Investigational Site Number 250004
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Investigational Site Number 250005
City
Strasbourg
ZIP/Postal Code
67200
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23426279
Citation
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.
Results Reference
derived

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SAR3419 in Acute Lymphoblastic Leukemia

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