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French Registry of First-line Treatment of Acute Promyelocytic Leukemia

Sponsor
Groupe Francophone des Myelodysplasies (Other)
Overall Status
Recruiting
CT.gov ID
NCT02938858
Collaborator
Teva Pharmaceuticals USA (Industry)
400
Enrollment
27
Locations
84
Duration (Months)
14.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years
    Study Start Date :
    Oct 1, 2015
    Anticipated Primary Completion Date :
    Oct 1, 2020
    Anticipated Study Completion Date :
    Oct 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    ATRA-chimio

    according to usual practice center
    ATRA-ATO

    according to usual practice center

    Outcome Measures

    Primary Outcome Measures

    1. Event-free survival [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

    Secondary Outcome Measures

    1. Rate of hematological complete remission [up to 30 days]

      from date of inclusion until end of induction therapy

    2. Rate of overall survival [at 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier d'Aix en Provence Aix en Provence France 13616
    2 Groupe Hospitalier SUD Amiens France 80054
    3 Centre Hospitalier V. Dupouy Argenteuil France 95107
    4 Hôpital Jean Minjoz Besançon France 25030
    5 CHU Bordeaux Pellegrin enfant Bordeaux France 33076
    6 CHRU de Brest - Pédiatrie Spécialisée Brest France 29609
    7 CHU Estaing Clermont-Ferrand France 63100
    8 Hôpital Henri Mondor Créteil France 94100
    9 CHU de Grenoble Grenoble France 38043
    10 Hopital Andre Mignot Le Chesnay France 78150
    11 CH Dr Schaffner Lens France 62307
    12 Chru - Hopital Claude Huriez Lille France 59037
    13 Hôpital universitaire Dupuytren Limoges France 87042
    14 Institut Paoli Calmettes Marseille France 13273
    15 Chu Timone Marseille France 13385
    16 CHR Metz-Thionville - Hôpital de Marcy Metz France 57085
    17 CHU Saint Eloi Montpellier France 34095
    18 CHU Hôtel Dieu Nantes France 44035
    19 Hôpital de la Source Orléans France 45100
    20 Hôpital TROUSSEAU Paris France 75012
    21 Hôpital Necker Paris France 75015
    22 Hôpital Robert Debré Paris France 75019
    23 CHU Hôpital Sud - service Hémato-oncologie Pédiatrique Rennes France 35203
    24 Hôpital V. Provo Roubaix France 59056
    25 Centre Henri Becquerel Rouen France 76038
    26 Institut de Cancerologie de La Loire Saint Priest-en-jarez France 42270
    27 IUCT Oncopole Toulouse France 31059

    Sponsors and Collaborators

    • Groupe Francophone des Myelodysplasies
    • Teva Pharmaceuticals USA

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Francophone des Myelodysplasies
    ClinicalTrials.gov Identifier:
    NCT02938858
    Other Study ID Numbers:
    • French registry APL
    First Posted:
    Oct 19, 2016
    Last Update Posted:
    Oct 19, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Promyelocytic, Acute

    Study Results

    No Results Posted as of Oct 19, 2016