French Registry of First-line Treatment of Acute Promyelocytic Leukemia

Acute Promyelocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02938858
• Other study ID #: French registry APL
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2016
• Last updated: October 17, 2016
• Start date: October 2015
• Est. completion date: October 2022

Study information

• Verified date: October 2016
• Source: Groupe Francophone des Myelodysplasies
• Contact: Pierre FENAUX, MD
• Phone: +33 1 71 20 70 18
• Email: pierre.fenaux[@]aphp.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 2022
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Years

Eligibility

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/RARa.

• 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Promyelocytic Leukemia
• Leukemia
• Leukemia, Promyelocytic, Acute

Locations

Country	Name	City	State
France	Centre Hospitalier d'Aix en Provence	Aix en Provence
France	Groupe Hospitalier SUD	Amiens
France	Centre Hospitalier V. Dupouy	Argenteuil
France	Hôpital Jean Minjoz	Besançon
France	CHU Bordeaux Pellegrin enfant	Bordeaux
France	CHRU de Brest - Pédiatrie Spécialisée	Brest
France	CHU Estaing	Clermont-Ferrand
France	Hôpital Henri Mondor	Créteil
France	CHU de Grenoble	Grenoble
France	Hopital Andre Mignot	Le Chesnay
France	CH Dr Schaffner	Lens
France	Chru - Hopital Claude Huriez	Lille
France	Hôpital universitaire Dupuytren	Limoges
France	Chu Timone	Marseille
France	Institut Paoli Calmettes	Marseille
France	CHR Metz-Thionville - Hôpital de Marcy	Metz
France	CHU Saint Eloi	Montpellier
France	CHU Hôtel Dieu	Nantes
France	Hôpital de la Source	Orléans
France	Hôpital Necker	Paris
France	Hôpital Robert Debré	Paris
France	Hôpital TROUSSEAU	Paris
France	CHU Hôpital Sud - service Hémato-oncologie Pédiatrique	Rennes
France	Hôpital V. Provo	Roubaix
France	Centre Henri Becquerel	Rouen
France	Institut de Cancerologie de La Loire	Saint Priest-en-jarez
France	IUCT Oncopole	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Francophone des Myelodysplasies	TEVA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	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	Yes
Secondary	Rate of hematological complete remission	from date of inclusion until end of induction therapy	up to 30 days	No
Secondary	Rate of overall survival		at 5 years	No