RecruitingPhase II/IIIEN originalLeukemia

Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek od 18 do 60 lat
  • Nowo rozpoznana białaczka szpikowa (de novo lub wtórna, na przykład po zespole mielodysplastycznym)
  • Brak wcześniejszego leczenia białaczki (poza hydroksymocznikiem) lub zespołu mielodysplastycznego
  • Stan ogólny pozwalający na leczenie (ECOG ≤ 3)
  • Brak poważnego niekontrolowanego zakażenia
  • Serce zdolne do tolerowania chemioterapii (frakcja wyrzutowa lewej komory ≥ 50%, brak zapaści serca)
  • Prawidłowe wyniki badań wątroby i nerek (chyba że zmienione przez chorobę)
  • Badanie genetyczne genu FLT3 wykonane w laboratorium

✗ Disqualifies

  • Ostra białaczka promielocytarna (APL)
  • Białaczka szpikowa z zaburzeniami in(8;21), t(16;16) lub inv(16)
  • Wtórna białaczka wywodząca się z wcześniejszych zaburzeń rozrostu szpiku

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
61 Years
Last updated (source)
July 17, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (56)

CH Amiens Hôpital Sud

Amiens, France

CHU Angers

Angers, France

CH Victor Dupouy

Argenteuil, France

Centre Hospitalier de la Côte Basque

Bayonne, France

Hôpital Jean Minjoz

Besançon, France

CH Beziers

Béziers, France

Hôpital Avicenne

Bobigny, France

CH Bordeaux

Bordeaux, France

Hôpital du Dr Duchenne

Boulogne-sur-Mer, France

Hôpital Morvan

Brest, France

CH Caen

Caen, France

Clinique du parc

Castelnau-le-Lez, France

Centre Hospitalier René Dubos

Cergy-Pontoise, France

HIA Percy

Clamart, France

CHU Estaing

Clermont-Ferrand, France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Hôpital Henri Mondor

Créteil, France

CHU de Dijon

Dijon, France

CH Dunkerque

Dunkirk, France

Hôpital Michallon

Grenoble, France

CH Versailles

Le Chesnay, France

CH Lens

Lens, France

CHRU de Lille, Hôpital Huriez

Lille, France

Hôpital St Vincent de Paul

Lille, France

CHU de Limoges

Limoges, France

Centre Leon Berard (CLB)

Lyon, France

CH Lyon Sud

Lyon, France

Marseille La Conception

Marseille, France

Institut Paoli Calmettes

Marseille, France

CH Meaux

Meaux, France

CHR Metz Thionville_Hôpital de Mercy

Metz, France

Hôpital Saint Eloi

Montpellier, France

CH Mulhouse

Mulhouse, France

CH Hôtel Dieu

Nantes, France

Centre Antoine Lacassagne

Nice, France

CHU Nice

Nice, France

CHRU de Nîmes

Nîmes, France

Hôpital Cochin

Paris, France

Hôpital La Pitié Salpêtrière

Paris, France

Hôpital Necker Enfants Malades

Paris, France

Hôpital Saint Antoine

Paris, France

Hôpital St Louis

Paris, France

Centre Hospitalier Saint Jean

Perpignan, France

CHU de Poitiers

Poitiers, France

Hôpital Robert Debré

Reims, France

CH Pontchaillou

Rennes, France

Hopital Victor Provo

Roubaix, France

Centre Henri Becquerel

Rouen, France

Hôpital René Huguenin

Saint-Cloud, France

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, France

Hôpital Hautepierre

Strasbourg, France

IUCT Toulouse

Toulouse, France

CHU Bretonneau

Tours, France

CH Valenciennes

Valenciennes, France

Hôpitaux de Brabois_CHU Nancy

Vandœuvre-lès-Nancy, France

Institut de Cancérologie Gustave Roussy

Villejuif, France

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/18/2026.

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