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 2

Recruiting

• Conditions: Acute Myeloid Leukemia (AML)
• Interventions: Drug: HD Cytarabine; Drug: ID cytarabine; Drug: Idarubicin; Drug: Cyclosporine; Drug: Methotrexate; Drug: vosaroxin; Drug: Daunorubicin; Drug: Mycophenolic acid (MPA); Drug: Dexamethasone; Drug: Venetoclax

• Registration Number: NCT02416388
• Lead Sponsor: University Hospital, Angers

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-07
• Study Completion: 2032-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R4-HDAC (without DEX)	HD Cytarabine	High dose cytarabine alone
R4-VEN-IDAC	ID cytarabine	Intermediate dose cytarabine and venetoclax
R2-IDAC	ID cytarabine	Intermediate dose cytarabine
R4-VOS-IDAC	ID cytarabine	Intermediate dose cytarabine and vosaroxin
R1-IDA	Idarubicin	Idarubicin
R3-MAC-MPA	Cyclosporine	Cyclosporine and mycophenolic acid
R4-DEX-HDAC	HD Cytarabine	High dose cytarabine and dexamethasone
R2-HDAC	HD Cytarabine	High dose cytarabine
R3-MAC-MPA	Mycophenolic acid (MPA)	Cyclosporine and mycophenolic acid
R3-RIC-MPA	Mycophenolic acid (MPA)	Cyclosporine and mycophenolic acid
R3-MAC-MTX	Methotrexate	Methotrexate and mycophenolic acid
R3-MAC-MTX	Mycophenolic acid (MPA)	Methotrexate and mycophenolic acid
R3-RIC-CICLO	Cyclosporine	Cyclosporine
R4-VOS-IDAC	vosaroxin	Intermediate dose cytarabine and vosaroxin
R4-DEX-HDAC	Dexamethasone	High dose cytarabine and dexamethasone
R4-IDAC (without VOS)	ID cytarabine	Intermediate dose cytarabine alone
R4-IDAC (without VEN)	ID cytarabine	Intermediate dose cytarabine alone
R3-RIC-MPA	Cyclosporine	Cyclosporine and mycophenolic acid
R1-DAUNO	Daunorubicin	Daunorubicin
R4-VEN-IDAC	Venetoclax	Intermediate dose cytarabine and venetoclax

Primary Outcome Measures

Name	Time	Method
Cumulative incidence (CI) of acute Graft versus Host Disease (GvHD) of grade II to IV	100 days	For randomization R3 : GvHD prophylaxis study
Disease free survival	18 months	For randomizations R4
Overall survival	3 years	For randomizations R1 (idarubicine vs daunorubicine) and R2 (HDAC vs IDAC)

Trial Locations

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; 🇫🇷 Besancon, France

CH Beziers; 🇫🇷 Beziers, France

Hôpital Avicenne; 🇫🇷 Bobigny, France

CH Bordeaux; 🇫🇷 Bordeaux, France

Hôpital du Dr Duchenne; 🇫🇷 Boulogne sur Mer, France

Hôpital Morvan; 🇫🇷 Brest, France

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