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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

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

NCT02416388•University Hospital, Angers

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 61 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years and \< 61 years
•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:
+48 more criteria

Exclusion Criteria

•1.Patients with acute promyelocytic leukemia (APL), as confirmed either by t(15;17) or by the presence of PML-RARA fusion transcripts 2.Patients with core binding factor (CBF) AML, as confirmed either by t(8;21), t(16,16) or inv(16), or by fusion transcripts resulting from these cytogenetic abnormalities (RUNX1-RUNX1T1, CBFB-MYH11).
•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) :
+12 more criteria

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

Key Dates

Start Date

January 1, 2015

Primary Completion Date

July 1, 2025

Completion Date

January 1, 2032

Last Updated

August 7, 2024

Enrollment

3,100

ESTIMATED participants

Conditions

Acute Myeloid Leukemia (AML)

Interventions

Idarubicin

DRUG

Daunorubicin

DRUG

HD Cytarabine

DRUG

Cyclosporine

DRUG

Methotrexate

DRUG

Mycophenolic acid (MPA)

DRUG

vosaroxin

DRUG

ID cytarabine

DRUG

Dexamethasone

DRUG

Venetoclax

DRUG

Contacts

Mathilde Hunault, PD

CONTACT

MaHunault@chu-angers.fr

DRCI Promotion Interne

CONTACT

+ 33 2 41 35 68 28 EcPromotionInterne@chu-angers.intra

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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