NCT02113319

Brief Summary

In patients with Core Binding Factors Acute Myelogenous Leukemia, the level of Minimal Residual Disease after chemotherapy is predictive of relapse. The relapse risk is also increased in case of mutations of receptors tyrosine kinase. For patients with a high Minimal Residual Disease level at the end of consolidation or in molecular relapse, maintenance by the inhibitor dasatinib is proposed.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
Last Updated

April 14, 2014

Status Verified

January 1, 2009

Enrollment Period

5.1 years

First QC Date

March 5, 2014

Last Update Submit

April 11, 2014

Conditions

Acute Myelogenous Leukemia

Keywords

Core Binding FactorsAcute Myelogenous Leukemia refractory to conventional chemotherapymolecular relapse

Outcome Measures

Primary Outcomes (1)

  • measure relapse-free survival

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    4 years

Study Arms (1)

dasatinib

EXPERIMENTAL
Drug: dasatinib

Interventions

dasatinibDRUG

dasatinib 50 mg and 20 mg During one year

dasatinib

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient presenting de novo or secondary Core Binding Factors Acute Myelogenous Leukemia
  • Patient in first and presenting one of following criteria:
  • "Resistant" Patient: decrease of less than 3 log of the Acute Myelogenous Leukemia transcript level in the bone marrow after 2 consolidations
  • Patient in " molecular relapse ": increase of of more than 1 log of the Core Acute Myelogenous Leukemia transcript level on two successive marrow samples

You may not qualify if:

  • Woman of childbearing potential
  • Concurrent incurable malignacy other than Acute Myelogenous Leukemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, 49 933, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

April 14, 2014

Study Start

April 1, 2007

Primary Completion

May 1, 2012

Last Updated

April 14, 2014

Record last verified: 2009-01

Locations

FR(1)