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French Registry of First-line Treatment of Acute Promyelocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02938858
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Groupe Francophone des Myelodysplasies

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
Acute Promyelocytic Leukemia

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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 : October 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

according to usual practice center
according to usual practice center

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Rate of hematological complete remission [ Time Frame: up to 30 days ]
    from date of inclusion until end of induction therapy

  2. Rate of overall survival [ Time Frame: at 5 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02938858

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Contact: Pierre FENAUX, MD +33 1 71 20 70 18
Contact: Ramy RAHME, MD + 33 1 71 20 70 22

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Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Teva Pharmaceuticals USA
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Principal Investigator: Pierre FENAUX, MD French APL Cooperative Group

Additional Information:

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Responsible Party: Groupe Francophone des Myelodysplasies Identifier: NCT02938858    
Other Study ID Numbers: French registry APL
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid, Acute
Leukemia, Myeloid