French Registry of First-line Treatment of Acute Promyelocytic Leukemia

October 17, 2016 updated by: Groupe Francophone des Myelodysplasies

The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years

The registry aims to compare the two first-line available treatment approaches in non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in terms of practitioner's choice between the two options, clinical effectiveness and cost-effectiveness, long-term outcome, and short- and long-term toxic effects.

Study Overview

Status

Unknown

Conditions

Detailed Description

  • Collection of epidemiological data on non-high-risk APL patients aged ≤ 70 years: age and sex distribution, medical history, prognostic factors (time to treatment start, severity of coagulopathy at presentation, Performance status…).
  • Documentation of clinical and biologic effectiveness of the two first-line treatment approaches available for non-high-risk APL patients.
  • Documentation of Minimal Residual Disease (MRD).
  • Correlation of clinical outcomes with the chosen therapy.
  • Validation of published prognostic factors and identification of new prognostic factors

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aix en Provence, France, 13616
        • Recruiting
        • Centre Hospitalier d'Aix en Provence
        • Contact:
      • Amiens, France, 80054
      • Argenteuil, France, 95107
      • Besançon, France, 25030
        • Recruiting
        • Hopital Jean Minjoz
        • Contact:
      • Bordeaux, France, 33076
      • Brest, France, 29609
        • Recruiting
        • CHRU de Brest - Pédiatrie Spécialisée
        • Contact:
      • Clermont-Ferrand, France, 63100
      • Créteil, France, 94100
      • Grenoble, France, 38043
      • Le Chesnay, France, 78150
        • Recruiting
        • Hopital Andre Mignot
        • Contact:
      • Lens, France, 62307
        • Recruiting
        • CH Dr Schaffner
        • Contact:
      • Lille, France, 59037
      • Limoges, France, 87042
      • Marseille, France, 13273
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
      • Marseille, France, 13385
        • Recruiting
        • CHU Timone
        • Contact:
      • Metz, France, 57085
      • Montpellier, France, 34095
      • Nantes, France, 44035
      • Orléans, France, 45100
      • Paris, France, 75015
      • Paris, France, 75019
        • Recruiting
        • Hôpital Robert Debré
        • Contact:
      • Paris, France, 75012
        • Recruiting
        • Hôpital Trousseau
        • Contact:
      • Rennes, France, 35203
        • Recruiting
        • CHU Hôpital Sud - service Hémato-oncologie Pédiatrique
      • Roubaix, France, 59056
      • Rouen, France, 76038
        • Recruiting
        • Centre Henri Becquerel
      • Saint Priest-en-jarez, France, 42270
      • Toulouse, France, 31059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

French patients with newly-diagnosed de novo or therapy-related non-high-risk APL (White Blood Count < 10000/μl) aged ≤ 70 years.

Description

Inclusion Criteria:

  • Newly-diagnosed APL (either de novo or therapy-related) based on cytologic criteria and confirmed by the presence of the t(15;17) translocation and/or by the detection of the fusion transcript PML/RARα.
  • Non-high-risk APL (White Blood Count < 10000/μl at presentation)
  • Age ≤ 70 years

Exclusion Criteria:

  • Relapsed APL
  • Newly-diagnosed High-risk APL (White Blood Count > 10000/μl at presentation)
  • Age > 70 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
ATRA-chimio
according to usual practice center
ATRA-ATO
according to usual practice center

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: From date of induction until the date of first documented event, assessed up to 60 months
events are: no achievement of haematological complete remission after induction therapy; no achievement of molecular remission after the consolidation courses; relapse; death including early death
From date of induction until the date of first documented event, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of hematological complete remission
Time Frame: up to 30 days
from date of inclusion until end of induction therapy
up to 30 days
Rate of overall survival
Time Frame: at 5 years
at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Francophone des Myelodysplasies

Collaborators

Teva Pharmaceuticals USA

Investigators

  • Principal Investigator: Pierre FENAUX, MD, French APL Cooperative Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • French registry APL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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