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Intermediate dose cytarabine and vosaroxin

Intermediate dose cytarabine and venetoclax

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).

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).

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

HD Cytarabine

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

GvHD prophylaxis post allogeneic SCT :

-15 mg/m² on D+1 then 10 mg/m² on D+3, D+6 and D+11

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

Mycophenolic acid (MPA)

Consolidation chemotherapy course (s) :

-70 mg/m² on D1 and D4

vosaroxin

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

ID cytarabine

Consolidation chemotherapy course (s) :

-10 mg/12h on D1, D3 and D5

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)

Mathilde Hunault, PD

Oliver Schmidt

Jean-Pierre Marolleau

Mathilde Hunault

Ahmad Al Jijakli

Anne Banos

Fabrice Larosa

Alain Saad

Claude Gardin

Arnaud Pigneux

Bachra Choufi

Gaelle Guillerm

Sylvain Chantepie

Ioana Vaida

Jean-Valère Malfuson

Aurelie Ravinet

Celia Salanoubat

Denis Caillot

Maxime Bemba

Jean-Yves Cahn

Philippe Rousselot

Laure STALNIKIEWICZ

Bruno Quesnel

Nathalie Cambier

Pascal Turlure

Amine Belhabri

Xavier Thomas

Norbert Vey

Jamilé Frayfer

Veronique Dorvaux

Yosr Hicheri

Mario Ojeda-Uribe

Pierre Peterlin

Lauris Gastaud

Thomas Cluzeau

Eric Jourdan

Didier Bouscary

Madalina Uzunov

Felipe Suarez

Ollivier Legrand

Emmanuel Raffoux

Laurence Sahnes

Maria Pilar Gallego-Hernanz

Chantal Himberlin

Marc Bernard

Isabelle Plantier

Emilie Lemasle

Jacques Vargaftig

Emmanuelle Tavernier

Bruno Lioure

Christian Recher

Emmanuel Gyan

Jose Fernandes

Gabrielle Roth-Guepin

Stephane De Botton

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.

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

Phase II/III Randomized Study to Improve Overall Survival 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 Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial

For randomizations R1 (idarubicine vs daunorubicine) and R2 (HDAC vs IDAC)

For randomization R3 : GvHD prophylaxis study

University Hospital, Angers

Spots Global Cancer Trial Database for id cytarabine