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
NCT ID: NCT02416388
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
3100 participants
INTERVENTIONAL
2015-01-31
2032-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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R1-IDA
Idarubicin
Idarubicin
Induction chemotherapy :
Idarubicin 9mg/m² /day, from D1 to D5 (IV, 30min)
\+ cytarabine 200mg/m²/day from D1 to D7 (IV 24 h)
Bone marrow aspirate on D15 : if medullary blasts rate \< 5% → G-CSF (5 μg/kg/day) until hematopoietic recovery (PNN ≥ 1 G/L).
R1-DAUNO
Daunorubicin
Daunorubicin
Induction chemotherapy :
Daunorubicin 90mg/m²/day, from D1 to D3 (IV, 30min)
\+ cytarabine 200mg/m² /day from D1 to D7 (IV 24 h)
Bone marrow aspirate on D15 : if medullary blasts rate \< 5% → G-CSF (5 μg/kg/day) until hematopoietic recovery (PNN ≥ 1 G/L).
R2-HDAC
High dose cytarabine
HD Cytarabine
Consolidation chemotherapy course (s) :
-High dose cytarabine: 3g/m² /12h on D1, D3 and D5
For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
Up to 3 consolidation courses, depending on the patient AML risk group
R2-IDAC
Intermediate dose cytarabine
ID cytarabine
Consolidation chemotherapy course (s) :
-Intermediate dose cytarabine: 1.5g/m² /12h on D1, D3 and D5
For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
Up to 3 consolidation courses, depending on the patient AML risk group
R3-MAC-MTX
Methotrexate and mycophenolic acid
Methotrexate
GvHD prophylaxis post allogeneic SCT :
-15 mg/m² on D+1 then 10 mg/m² on D+3, D+6 and D+11
Mycophenolic acid (MPA)
GvHD prophylaxis post allogeneic SCT :
* 720 mg BID from D0 to D+28 for HLA-identical siblings
* 720 mg BID from D0 to D+45 for 10/10 HLA allele-matched unrelated donors
R3-MAC-MPA
Cyclosporine and mycophenolic acid
Cyclosporine
GvHD prophylaxis post allogeneic SCT :
-Cyclosporine : 3 mg/kg /day from D-1 (IV) or 6 mg/kg/day from D-3 (PO). Not to be stopped before D100
Mycophenolic acid (MPA)
GvHD prophylaxis post allogeneic SCT :
* 720 mg BID from D0 to D+28 for HLA-identical siblings
* 720 mg BID from D0 to D+45 for 10/10 HLA allele-matched unrelated donors
R3-RIC-CICLO
Cyclosporine
Cyclosporine
GvHD prophylaxis post allogeneic SCT :
-Cyclosporine : 3 mg/kg /day from D-1 (IV) or 6 mg/kg/day from D-3 (PO). Not to be stopped before D100
R3-RIC-MPA
Cyclosporine and mycophenolic acid
Cyclosporine
GvHD prophylaxis post allogeneic SCT :
-Cyclosporine : 3 mg/kg /day from D-1 (IV) or 6 mg/kg/day from D-3 (PO). Not to be stopped before D100
Mycophenolic acid (MPA)
GvHD prophylaxis post allogeneic SCT :
* 720 mg BID from D0 to D+28 for HLA-identical siblings
* 720 mg BID from D0 to D+45 for 10/10 HLA allele-matched unrelated donors
R4-VOS-IDAC
Intermediate dose cytarabine and vosaroxin
vosaroxin
Consolidation chemotherapy course (s) :
-70 mg/m² on D1 and D4
ID cytarabine
Consolidation chemotherapy course (s) :
-Intermediate dose cytarabine: 1.5g/m² /12h on D1, D3 and D5
For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
Up to 3 consolidation courses, depending on the patient AML risk group
R4-IDAC (without VOS)
Intermediate dose cytarabine alone
ID cytarabine
Consolidation chemotherapy course (s) :
-Intermediate dose cytarabine: 1.5g/m² /12h on D1, D3 and D5
For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
Up to 3 consolidation courses, depending on the patient AML risk group
R4-DEX-HDAC
High dose cytarabine and dexamethasone
HD Cytarabine
Consolidation chemotherapy course (s) :
-High dose cytarabine: 3g/m² /12h on D1, D3 and D5
For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
Up to 3 consolidation courses, depending on the patient AML risk group
Dexamethasone
Consolidation chemotherapy course (s) :
-10 mg/12h on D1, D3 and D5
R4-HDAC (without DEX)
High dose cytarabine alone
HD Cytarabine
Consolidation chemotherapy course (s) :
-High dose cytarabine: 3g/m² /12h on D1, D3 and D5
For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
Up to 3 consolidation courses, depending on the patient AML risk group
R4-VEN-IDAC
Intermediate dose cytarabine and venetoclax
ID cytarabine
Consolidation chemotherapy course (s) :
-Intermediate dose cytarabine: 1.5g/m² /12h on D1, D3 and D5
For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
Up to 3 consolidation courses, depending on the patient AML risk group
Venetoclax
Consolidation chemotherapy course (s) :
Once RP2D has been determined from the results of the dose selection phase (phase 1), the optimal dose level retained for randomized phase 2 will be one of the following:
* 100 mg/d on D1 to D8 (selection phase dose level 1)
* or 200 mg/d on D1 to D8 (selection phase dose level 2)
* or 400 mg/d on D1 to D8 (selection phase dose level 3)
* or 400 mg/d on D1 to D14 (selection phase dose level 4)
R4-IDAC (without VEN)
Intermediate dose cytarabine alone
ID cytarabine
Consolidation chemotherapy course (s) :
-Intermediate dose cytarabine: 1.5g/m² /12h on D1, D3 and D5
For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
Up to 3 consolidation courses, depending on the patient AML risk group
Interventions
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Idarubicin
Induction chemotherapy :
Idarubicin 9mg/m² /day, from D1 to D5 (IV, 30min)
\+ cytarabine 200mg/m²/day from D1 to D7 (IV 24 h)
Bone marrow aspirate on D15 : if medullary blasts rate \< 5% → G-CSF (5 μg/kg/day) until hematopoietic recovery (PNN ≥ 1 G/L).
Daunorubicin
Induction chemotherapy :
Daunorubicin 90mg/m²/day, from D1 to D3 (IV, 30min)
\+ cytarabine 200mg/m² /day from D1 to D7 (IV 24 h)
Bone marrow aspirate on D15 : if medullary blasts rate \< 5% → G-CSF (5 μg/kg/day) until hematopoietic recovery (PNN ≥ 1 G/L).
HD Cytarabine
Consolidation chemotherapy course (s) :
-High dose cytarabine: 3g/m² /12h on D1, D3 and D5
For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
Up to 3 consolidation courses, depending on the patient AML risk group
Cyclosporine
GvHD prophylaxis post allogeneic SCT :
-Cyclosporine : 3 mg/kg /day from D-1 (IV) or 6 mg/kg/day from D-3 (PO). Not to be stopped before D100
Methotrexate
GvHD prophylaxis post allogeneic SCT :
-15 mg/m² on D+1 then 10 mg/m² on D+3, D+6 and D+11
Mycophenolic acid (MPA)
GvHD prophylaxis post allogeneic SCT :
* 720 mg BID from D0 to D+28 for HLA-identical siblings
* 720 mg BID from D0 to D+45 for 10/10 HLA allele-matched unrelated donors
vosaroxin
Consolidation chemotherapy course (s) :
-70 mg/m² on D1 and D4
ID cytarabine
Consolidation chemotherapy course (s) :
-Intermediate dose cytarabine: 1.5g/m² /12h on D1, D3 and D5
For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
Up to 3 consolidation courses, depending on the patient AML risk group
Dexamethasone
Consolidation chemotherapy course (s) :
-10 mg/12h on D1, D3 and D5
Venetoclax
Consolidation chemotherapy course (s) :
Once RP2D has been determined from the results of the dose selection phase (phase 1), the optimal dose level retained for randomized phase 2 will be one of the following:
* 100 mg/d on D1 to D8 (selection phase dose level 1)
* or 200 mg/d on D1 to D8 (selection phase dose level 2)
* or 400 mg/d on D1 to D8 (selection phase dose level 3)
* or 400 mg/d on D1 to D14 (selection phase dose level 4)
Eligibility Criteria
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Inclusion Criteria
2. With a newly diagnosed de novo or secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)
3. No prior treatment for neither AML (with the exception of hydroxyurea), nor MDS (with the exception of EPO)
4. ECOG performance status ≤ 3
5. Absence of severe uncontrolled infection
6. No cardiac contraindications for the use of anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) \< 50%
7. Total bilirubin ≤ 2 x upper limit of normal (UNL), ASAT(SGOT) and ALAT (SGPT) ≤ 2.5 X UNL, creatinine \< 150 µmol/l, unless AML-related out of range values
8. Genetic mutation testing of the FLT3 (FLT3-ITD ou FLT3-TKD) gene, performed in local or central laboratory
9. Use of appropriate methods of contraception:
* for patients treated with Midostaurin:
* women of childbearing potential should use appropriate methods of contaception throughout treatment, and for 5 months post cessation of treatment
* men will need to use condoms during intercourse throughout treatment, and for 5 months post cessation of treatment with Midostaurin
10. Patients who are covered by or beneficiaries of a social security system (Social Security or Universal Medical Coverage)
11. Patients who have read and understood the information sheet and signed the informed consent form
1. Patients enrolled in the BIG-1 trial at diagnosis
2. Patient presenting with AML in first CR or CRp/CRi after induction or one cycle of salvage therapy (confirmed in the 15 days preceding R4-VOS)
3. Favorable or intermediate risk AML patients, as stratified with BIG-1 prognostic classification
4. Patients randomized to R2-IDAC arm (intermediate dose cytarabine)
5. ECOG performance status ≤ 2
6. Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
7. Local clinical laboratory values as follows:
o Serum creatinine ≤ 2.0 mg/dL
o Total bilirubin ≤ 1.5 X the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 X ULN
* Alanine aminotransferase (ALT) ≤ 2.5 X ULN
8. Signed written informed consent for vosaroxin study (R4-VOS)
9. Women of childbearing potential must have a negative pregnancy test within 8 days before randomization R4-VOS and commit to the use of effective contraception during the period of treatment and up to 36 days after vosaroxin has been stopped. Men must use effective contraception during the treatment period and up to 96 days after vosaroxin has been stopped.
1. Patients enrolled in the BIG-1 trial at diagnosis
2. Patient presenting with AML in first CR or CRp/CRi after induction or one cycle of salvage therapy (confirmed in the 15 days preceding R4-DEX)
3. Favorable or intermediate risk AML patients, as stratified with BIG-1 prognostic classification
4. ECOG performance status ≤ 2
5. Local clinical laboratory values as follows:
* Serum creatinine ≤ 150 µmol/L
* Total bilirubin ≤ 1.5 X the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 X ULN
* Alanine aminotransferase (ALT) ≤ 2.5 X ULN
6. Signed written informed consent for dexamethasone study (R4-DEX)
1. Age 18 - 60 years at inclusion in BIG-1 protocol
2. diagnosis of AML according to WHO classification de novo or secondary to myelodysplastic syndrome (myelodysplastic syndrome must not have been treated except by ESA, Lenalidomide or non-chemotherapy) or therapy-related AML
3. Patients included in the BIG-1 protocol
4. Patients in first CR or CRp/CRi following 1 or 2 courses of induction chemotherapy according to BIG-1 protocol and who are planned to receive consolidation.
5. Patients stratified within the favorable and intermediate risk groups as defined by BIG-1 protocol
6. ECOG performance status ≤ 2
7. Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
8. Creatinine clearance ≥ 30 ml/min (calculated by the usual method of each institution), total bilirubin ≤ 1.5 times the ULN; ASAT and ALAT ≤ times the upper limit of normal (ULN)
9. Absence of uncontrolled infection
10. Women of childbearing potential must agree to use effective contraception without interruption throughout the study and for a further 3 months after the end of treatment
11. Written signed informed consent
1. Patients enrolled in the BIG-1 trial at diagnosis
2. Patient presenting with AML in first CR or CRp/CRi treated in the BIG-1 trial and classified in the intermediate risk group, namely:
* either initially favorable but poor molecular responders for NPM1 MRD: NPM1 mutation, without FLT3-ITD mutation or with an FLT3-ITD ratio \< 0.50 and MRD2 positive blood (decrease of less than 4 log from baseline at diagnosis)).
* Or initially favorable but requiring two cycles of chemotherapy (a salvage therapy) to obtain the first CR/CRp/CRi
* Or other immediate intermediaries
3. No metastatic or progressive cancer, with the exception of basal cell skin carcinoma and cervical carcinoma in situ
4. Patients with general condition preserved (ECOG ≤ 3) and with no uncontrolled severe infection
5. Women of childbearing age must make use of effective contraception
6. Patients who are covered by or beneficiaries of a social security system (Social Security or Universal Medical Coverage).
7. Patients who have read and understood the information sheet and signed the informed consent form
Exclusion Criteria
3.Patients with secondary AML arising from myeloproliferative disorders previously known according to the 2008 WHO classification 4.Patients with Ph1+ AML or previous Ph1+ disorder (chronic myelogenous leukemia) 5.Severe psychiatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment, including allogeneic HSCT 6.No psychological, familial, social, or geographic reason that would compromise clinical follow up 7.History of uncontrolled cancer for the last 2 years, with the exception of basal cell carcinoma or carcinoma in situ of the cervix 8.Uncontrolled severe infection 9.Patients with positive serology for HIV-1 and -2, or HTLV -1 and -2, or active hepatitis virus B or C infection 10.Pregnant or lactating women 11.Legal incapacity (patients under tutorship, curatorship or judicial protection)
\------------------------------------------
For randomization R4-VOS (post-induction/salvage) :
1.Patients classified in the unfavorable risk group according to the BIG-1 protocol classification 2.Complete remission is not attained (CR, CRp/CRi) after induction and/or salvage therapy 3.Positive pregnancy test 4.Severe uncontrolled infection such as sepsis, or multiple organ dysfunction syndrome, uncontrolled fever 5.Documented uncontrolled fungal infection (positive blood test and cultures) 6.History of myocardial infarction, unstable angina, cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months before randomization 7.Patient under hemodialysis (HD) or peritoneal dialysis (PD)
\------------------------------------------
For randomization R4-DEX (post-induction/salvage) :
1.Severe uncontrolled infection such as sepsis, or multiple organ dysfunction syndrome, uncontrolled fever 2.Documented uncontrolled fungal infection (positive blood test and cultures 3.History of myocardial infarction, unstable angina, cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months before randomization 4.Patient under hemodialysis (HD) or peritoneal dialysis (PD)
\--------------------------------------
For randomization R4-VEN (post-induction/salvage) :
1.AML stratified in the unfavorable BIG-1 risk-group. 2.Diagnosis of Acute Promyelocytic Leukemia or CBF AML (ie. AML with t(8;21), t(16,16) or inv(16), or their molecular equivalents RUNX1-RUNX1T1 and CBFB-MYH11) 3.AML secondary to prior myeloproliferative disorder according to WHO classification (2008) and Philadelphia chromosome-positive AML (Ph1+) 4.Absence of CR/CRp/CRi after a maximum of two chemotherapy cycles 5.Severe medical or mental condition precluding the administration of protocol treatments 6.Prior history of cancer unless controlled for at least 2 years and except for basocellular cutaneous cancers and in situ cervix cancers 7.Positive pregnancy test 8.Breast feeding 9.Uncontrolled infection such as sepsis, or multiple organ dysfunction syndrome, uncontrolled fever 10.Documented uncontrolled fungal infection (positive blood test and cultures) 11.Prior venetoclax exposure 12.Known HBV with detectable viral load 13.Known HIV positive patients 14.Known hypersensitivity to any of the study medication 15.History of myocardial infarction, unstable angina, cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months before randomization 16.Patient under hemodialysis (HD) or peritoneal dialysis (PD) 17.Concomitant treatment with cytochrome CYP3A4 inhibitor which cannot be stopped during venetoclax administration ONLY FOR PHASE 1 18.During the phase 2, for patients randomized in the IDAC + Venetoclax arm, if concomitant treatment with cytochrome CYP3A4 inhibitor cannot be stopped, a dose reduction of 70% of venetoclax must be apply
\--------------------------------------
For randomization R3 (before AlloHSCT):
1. Complete remission is not obtained (CR, CRp/CRi) after induction and/or salvage therapy
2. Patient presenting with AML in first CR or CRp/CRi treated in the BIG-1 trial and classified either in the favorable risk group or the unfavorable risk group
3. Patients with a severe organ or psychiatric pathology, presumed to be independent of AML and contraindicating the allograft
4. Patients who, for family, social or geographic reasons, do not wish to be regularly monitored via consultation
5. Uncontrolled severe infection at the time of inclusion
6. Serology positive for HIV 1 or 2 or HTLV 1 or 2, or active HBV or HCV viral infection
7. Pregnant women (beta-HCG positive) or currently breastfeeding
8. Adult patient who is incapacitated, under wardship, legal guardianship, or under the protection of the courts
9. Patients under State Medical Assistance (AME)
18 Years
61 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Jean-Pierre Marolleau
Role: primary
Anne Banos
Role: primary
Fabrice Larosa
Role: primary
Claude Gardin
Role: primary
Arnaud Pigneux
Role: primary
Bachra Choufi
Role: primary
Sylvain Chantepie
Role: primary
Jean-Valère Malfuson
Role: primary
Maxime Bemba
Role: primary
Jean-Yves Cahn
Role: primary
Philippe Rousselot
Role: primary
Nathalie Cambier
Role: primary
Pascal Turlure
Role: primary
Xavier Thomas
Role: primary
Norbert Vey
Role: primary
Jamilé Frayfer
Role: primary
Yosr Hicheri
Role: primary
Mario Ojeda-Uribe
Role: primary
Pierre Peterlin
Role: primary
Lauris Gastaud
Role: primary
Thomas Cluzeau
Role: primary
Didier Bouscary
Role: primary
Madalina Uzunov
Role: primary
Felipe Suarez
Role: primary
Emmanuel Raffoux
Role: primary
Maria Pilar Gallego-Hernanz
Role: primary
Marc Bernard
Role: primary
Isabelle Plantier
Role: primary
Emilie Lemasle
Role: primary
Jacques Vargaftig
Role: primary
Emmanuelle Tavernier
Role: primary
Bruno Lioure
Role: primary
Christian Recher
Role: primary
Jose Fernandes
Role: primary
Stephane De Botton
Role: primary
References
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Hunault M, Pautas C, Bertoli S, Dumas PY, Raffoux E, Hospital MA, Marchand T, Heiblig M, Chantepie S, Carre M, Peterlin P, Gallego-Hernanz MP, Lemasle E, Guieze R, Simand C, Turlure P, Huynh A, Leguay T, Devillier R, Quoc SN, Duployez N, Luquet I, Penther D, Celli-Lebras K, Mineur A, Raus N, Gardin C, Socie G, Cahn JY, Ifrah N, Vey N, de Latour RP, Delabesse E, Preudhomme C, Hamel JF, Pigneux A, Recher C, Dombret H. Intermediate-Dose Cytarabine as Postinduction AML Therapy. NEJM Evid. 2025 Jul;4(7):EVIDoa2400326. doi: 10.1056/EVIDoa2400326. Epub 2025 Jun 24.
Other Identifiers
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PHRC-2010-03
Identifier Type: -
Identifier Source: org_study_id
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