Acute Promyelocytic LeukemiaNCT02938858
French Registry of First-line Treatment of Acute Promyelocytic Leukemia
An observational study of Acute Promyelocytic Leukemia, run by Groupe Francophone des Myelodysplasies at 27 sites in France.
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… Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Acute Promyelocytic Leukemia
- How many people
- 400 participants
- Where
- 27 sitesFrance
- Study dates
- Oct 2015to Jul 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: French patients with newly-diagnosed de novo or therapy-related non-high-risk APL (White Blood Count < 10000/μl) aged ≤ 70 years.
Who may be able to join
- 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
Who cannot join
- Relapsed APL
- Newly-diagnosed High-risk APL (White Blood Count > 10000/μl at presentation)
- Age > 70 years
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
Centre Hospitalier d'Aix en Provence
Aix-en-Provence, 13616
Groupe Hospitalier SUD
Amiens, 80054
Centre Hospitalier V. Dupouy
Argenteuil, 95107
Hôpital Jean Minjoz
Besançon, 25030
CHU Bordeaux Pellegrin enfant
Bordeaux, 33076
CHRU de Brest - Pédiatrie Spécialisée
Brest, 29609
CHU Estaing
Clermont-Ferrand, 63100
Hôpital Henri Mondor
Créteil, 94100
CHU de Grenoble
Grenoble, 38043
Hopital Andre Mignot
Le Chesnay, 78150
CH Dr Schaffner
Lens, 62307
Chru - Hopital Claude Huriez
Lille, 59037
Hôpital universitaire Dupuytren
Limoges, 87042
Institut Paoli Calmettes
Marseille, 13273
Chu Timone
Marseille, 13385
CHR Metz-Thionville - Hôpital de Marcy
Metz, 57085
CHU Saint Eloi
Montpellier, 34095
CHU Hôtel Dieu
Nantes, 44035
Hôpital de la Source
Orléans, 45100
Hôpital TROUSSEAU
Paris, 75012
Hôpital Necker
Paris, 75015
Hôpital Robert Debré
Paris, 75019
CHU Hôpital Sud - service Hémato-oncologie Pédiatrique
Rennes, 35203
Hôpital V. Provo
Roubaix, 59056
Centre Henri Becquerel
Rouen, 76038
Institut de Cancerologie de La Loire
Saint-Priest-en-Jarez, 42270
IUCT Oncopole
Toulouse, 31059
About this study
Official title: 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.
Read the 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
- Conditions
- Acute Promyelocytic Leukemia
- Medical subject headings
- Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ATRA-chimio | according to usual practice center | |
| ATRA-ATO | according to usual practice center |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From date of induction until the date of first documented event, assessed up to 60 months
Secondary outcomes (2)
Rate of hematological complete remission
from date of inclusion until end of induction therapy
Measured: up to 30 days
Rate of overall survival
Overall survival defined as the time from inclusion until death or end of follow-up
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2015
- Primary completionJul 2026
- Study completionJul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Promyelocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Groupe Francophone des Myelodysplasies
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
- Investigators
- Pierre FENAUX, MD, Principal investigator, French APL Cooperative Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938858
- Sponsor's protocol ID
- French registry APL
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2016
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years
- ClinicalTrials.gov ID
- NCT02938858
- Acronym / sponsor ID
- French registry APL
- Conditions
- Acute Promyelocytic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Groupe Francophone des MyelodysplasiesUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- Oct 2015
- Primary completion
- Jul 2026 (actual)
- Study completion
- Jul 2026 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATRA-chimio | – | –according to usual practice center |
| ATRA-ATO | – | –according to usual practice center |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- French patients with newly-diagnosed de novo or therapy-related non-high-risk APL (White Blood Count < 10000/μl) aged ≤ 70 years.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Relapsed APL
- Newly-diagnosed High-risk APL (White Blood Count > 10000/μl at presentation)
- Age > 70 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Rate of hematological complete remission
Time frame: up to 30 days
Rate of overall survival
Time frame: at 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre FENAUX, MD principal investigator
French APL Cooperative Group
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Promyelocytic Leukemia, run by Groupe Francophone des Myelodysplasies at 27 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: From date of induction until the date of first documented event, assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.