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| Name | Class |
|---|---|
| Teva Pharmaceuticals USA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATRA-chimio | according to usual practice center | ||
| ATRA-ATO | according to usual practice center |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of hematological complete remission | from date of inclusion until end of induction therapy | up to 30 days |
| Rate of overall survival | Overall survival defined as the time from inclusion until death or end of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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French patients with newly-diagnosed de novo or therapy-related non-high-risk APL (White Blood Count < 10000/μl) aged ≤ 70 years.
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| Name | Affiliation | Role |
|---|---|---|
| Pierre FENAUX, MD | French APL Cooperative Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Aix en Provence | Aix-en-Provence | 13616 | France | |||
| Groupe Hospitalier SUD |
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| at 5 years |
| Amiens |
| 80054 |
| France |
| Centre Hospitalier V. Dupouy | Argenteuil | 95107 | France |
| Hôpital Jean Minjoz | Besançon | 25030 | France |
| CHU Bordeaux Pellegrin enfant | Bordeaux | 33076 | France |
| CHRU de Brest - Pédiatrie Spécialisée | Brest | 29609 | France |
| CHU Estaing | Clermont-Ferrand | 63100 | France |
| Hôpital Henri Mondor | Créteil | 94100 | France |
| CHU de Grenoble | Grenoble | 38043 | France |
| Hopital Andre Mignot | Le Chesnay | 78150 | France |
| CH Dr Schaffner | Lens | 62307 | France |
| Chru - Hopital Claude Huriez | Lille | 59037 | France |
| Hôpital universitaire Dupuytren | Limoges | 87042 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Chu Timone | Marseille | 13385 | France |
| CHR Metz-Thionville - Hôpital de Marcy | Metz | 57085 | France |
| CHU Saint Eloi | Montpellier | 34095 | France |
| CHU Hôtel Dieu | Nantes | 44035 | France |
| Hôpital de la Source | Orléans | 45100 | France |
| Hôpital TROUSSEAU | Paris | 75012 | France |
| Hôpital Necker | Paris | 75015 | France |
| Hôpital Robert Debré | Paris | 75019 | France |
| CHU Hôpital Sud - service Hémato-oncologie Pédiatrique | Rennes | 35203 | France |
| Hôpital V. Provo | Roubaix | 59056 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Institut de Cancerologie de La Loire | Saint-Priest-en-Jarez | 42270 | France |
| IUCT Oncopole | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D015473 | Leukemia, Promyelocytic, Acute |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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