Actively Recruiting
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
Led by University Hospital, Angers · Updated on 2024-08-07
3100
Participants Needed
56
Research Sites
887 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and less than 61 years
- Newly diagnosed de novo or secondary AML
- No prior AML treatment except hydroxyurea
- ECOG performance status 3 or less
- No severe uncontrolled infection
- No cardiac contraindications for anthracyclines (e.g., heart failure, recent heart attack, LVEF less than 50%)
- Liver and kidney function within specified limits unless related to AML
- Genetic testing for FLT3 mutation performed
- Use of effective contraception as required for certain treatments
- Covered by social security or universal medical coverage
- Signed informed consent
- AML in first complete remission or partial remission after induction or salvage therapy for certain randomizations
- Favorable or intermediate risk AML for specific treatment phases
- Ability to undergo required laboratory and cardiac function tests
- Women of childbearing potential with negative pregnancy test as applicable
- No metastatic or progressive cancer except certain skin or cervical cancers
- General condition preserved (ECOG 3 or less)
- Willingness to comply with contraception and follow-up requirements
You will not qualify if you...
- Acute promyelocytic leukemia (APL) or core binding factor AML
- Secondary AML from myeloproliferative disorders or Philadelphia chromosome-positive AML
- Severe psychiatric or organic disorders contraindicating treatment
- Psychological, social, or geographic reasons compromising follow-up
- History of uncontrolled cancer within 2 years except specific exceptions
- Uncontrolled severe infection
- Positive HIV, HTLV, or active hepatitis B or C infection
- Pregnant or breastfeeding women
- Legal incapacity or under legal protection
- Unfavorable risk AML for specific randomizations
- Failure to achieve remission after induction or salvage therapy
- History of recent severe cardiovascular events
- Undergoing dialysis
- Prior venetoclax exposure or hypersensitivity to study drugs
- Concomitant use of certain CYP3A4 inhibitors as specified
- Severe medical or mental conditions precluding treatment
- Positive pregnancy test or breastfeeding during certain study phases
- Patients under state medical assistance (AME) where noted
AI-Screening
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Trial Site Locations
Total: 56 locations
1
CH Amiens Hôpital Sud
Amiens, France
Actively Recruiting
2
CHU Angers
Angers, France, 49100
Actively Recruiting
3
CH Victor Dupouy
Argenteuil, France
Actively Recruiting
4
Centre Hospitalier de la Côte Basque
Bayonne, France
Actively Recruiting
5
Hôpital Jean Minjoz
Besançon, France
Actively Recruiting
6
CH Beziers
Béziers, France
Actively Recruiting
7
Hôpital Avicenne
Bobigny, France
Actively Recruiting
8
CH Bordeaux
Bordeaux, France
Actively Recruiting
9
Hôpital du Dr Duchenne
Boulogne-sur-Mer, France
Actively Recruiting
10
Hôpital Morvan
Brest, France
Actively Recruiting
11
CH Caen
Caen, France
Actively Recruiting
12
Clinique du parc
Castelnau-le-Lez, France, 34170
Withdrawn
13
Centre Hospitalier René Dubos
Cergy-Pontoise, France
Actively Recruiting
14
HIA Percy
Clamart, France
Actively Recruiting
15
CHU Estaing
Clermont-Ferrand, France
Actively Recruiting
16
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Actively Recruiting
17
Hôpital Henri Mondor
Créteil, France
Actively Recruiting
18
CHU de Dijon
Dijon, France
Actively Recruiting
19
CH Dunkerque
Dunkirk, France
Actively Recruiting
20
Hôpital Michallon
Grenoble, France
Actively Recruiting
21
CH Versailles
Le Chesnay, France
Actively Recruiting
22
CH Lens
Lens, France
Actively Recruiting
23
CHRU de Lille, Hôpital Huriez
Lille, France
Actively Recruiting
24
Hôpital St Vincent de Paul
Lille, France
Actively Recruiting
25
CHU de Limoges
Limoges, France
Actively Recruiting
26
Centre Leon Berard (CLB)
Lyon, France
Actively Recruiting
27
CH Lyon Sud
Lyon, France
Actively Recruiting
28
Marseille La Conception
Marseille, France, 13005
Actively Recruiting
29
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
30
CH Meaux
Meaux, France
Actively Recruiting
31
CHR Metz Thionville_Hôpital de Mercy
Metz, France
Actively Recruiting
32
Hôpital Saint Eloi
Montpellier, France
Actively Recruiting
33
CH Mulhouse
Mulhouse, France
Actively Recruiting
34
CH Hôtel Dieu
Nantes, France
Actively Recruiting
35
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
36
CHU Nice
Nice, France
Actively Recruiting
37
CHRU de Nîmes
Nîmes, France
Actively Recruiting
38
Hôpital Cochin
Paris, France
Actively Recruiting
39
Hôpital La Pitié Salpêtrière
Paris, France
Actively Recruiting
40
Hôpital Necker Enfants Malades
Paris, France
Actively Recruiting
41
Hôpital Saint Antoine
Paris, France
Actively Recruiting
42
Hôpital St Louis
Paris, France
Actively Recruiting
43
Centre Hospitalier Saint Jean
Perpignan, France
Actively Recruiting
44
CHU de Poitiers
Poitiers, France
Actively Recruiting
45
Hôpital Robert Debré
Reims, France
Actively Recruiting
46
CH Pontchaillou
Rennes, France
Actively Recruiting
47
Hopital Victor Provo
Roubaix, France
Actively Recruiting
48
Centre Henri Becquerel
Rouen, France
Actively Recruiting
49
Hôpital René Huguenin
Saint-Cloud, France
Actively Recruiting
50
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France
Actively Recruiting
51
Hôpital Hautepierre
Strasbourg, France
Actively Recruiting
52
IUCT Toulouse
Toulouse, France
Actively Recruiting
53
CHU Bretonneau
Tours, France
Actively Recruiting
54
CH Valenciennes
Valenciennes, France
Actively Recruiting
55
Hôpitaux de Brabois_CHU Nancy
Vandœuvre-lès-Nancy, France
Actively Recruiting
56
Institut de Cancérologie Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
M
Mathilde Hunault, PD
CONTACT
D
DRCI Promotion Interne
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
14
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