Clinical trial NCT02938858: French Registry of First-line Treatment of Acute Promyelocytic Leukemia
Official title: The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Promyelocytic Leukemia
Lead sponsor: Groupe Francophone des Myelodysplasies
Sponsor class: OTHER
Collaborators: name: Teva Pharmaceuticals USA
First posted: 2016-10-19
Enrollment: 400
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Event-free survival
timeFrame: From date of induction until the date of first documented event, assessed up to 60 months
Secondary outcomes:
measure: Rate of hematological complete remission
timeFrame: up to 30 days
measure: Rate of overall survival
timeFrame: at 5 years
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre Hospitalier d'Aix en Provence
city: Amiens
country: France
facility: Groupe Hospitalier SUD
city: Argenteuil
country: France
facility: Centre Hospitalier V. Dupouy
city: Besançon
country: France
facility: Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: CHU Bordeaux Pellegrin enfant
city: Brest
country: France
facility: CHRU de Brest - Pédiatrie Spécialisée
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Chesnay
country: France
facility: Hopital Andre Mignot
city: Lens
country: France
facility: CH Dr Schaffner
city: Lille
country: France
facility: Chru - Hopital Claude Huriez
city: Limoges
country: France
facility: Hôpital universitaire Dupuytren
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Marseille
country: France
facility: Chu Timone
city: Metz
country: France
facility: CHR Metz-Thionville - Hôpital de Marcy
city: Montpellier
country: France
facility: CHU Saint Eloi
city: Nantes
country: France
facility: CHU Hôtel Dieu
city: Orléans
country: France
facility: Hôpital de la Source
city: Paris
country: France
facility: Hôpital TROUSSEAU
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Hôpital Robert Debré
city: Rennes
country: France
facility: CHU Hôpital Sud - service Hémato-oncologie Pédiatrique
city: Roubaix
country: France
facility: Hôpital V. Provo
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Priest-en-jarez
country: France
facility: Institut de Cancerologie de La Loire
city: Toulouse
country: France
facility: IUCT Oncopole
Study officials:
affiliation: French APL Cooperative Group
name: Pierre FENAUX, MD
role: PRINCIPAL_INVESTIGATOR
References: