A MULTICENTRIC PHASE 2 STUDY OF VENETOCLAX AND AZACITIDINE FOR THE MANAGEMENT OF MOLECULAR RELAPSE/PROGRESSION IN ADULT NPM1-MUTATED ACUTE MYELOID LEUKEMIA. AML2521

Conditions

Acute Myeloid Leukemia with NPM1 mutation

Brief summary

Percentage of patients who do not experience overt relapse at 6 months or within stem cell transplant

Detailed description

MRD negativity rate at 3 and 6 months and at transplant, Percentage of patients undergoing alloSCT in CR, Percentage of patients undergoing alloSCT in MRD negativity, Disease Progression rate at 3, 6 and 12 months and at transplant, Molecular Disease Progression at 3, 6 and 12 months and at transplant, Overall Survival (OS), defined as the number of days between the first study drug administration and death from any cause or lost to follow up., Progression-Free Survival (PFS), defined as the number of days between the first study drug administration and any event including disease progression or death., Molecular Disease-Free Survival (MDFS), defined as the number of days between the data of response (MRD negativity) and molecular disease progression or death., Molecular progression-free survival (MPFS), defined as the number of days between the first study drug administration and molecular disease progression or death., Safety and toxicity of venetoclax-azacitidine in the experimental setting

Related papers

No related papers found yet.

Interventions

DRUGVENETOCLAX

DRUGAZACITIDINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of patients who do not experience overt relapse at 6 months or within stem cell transplant	—

Secondary

Measure	Time frame
MRD negativity rate at 3 and 6 months and at transplant, Percentage of patients undergoing alloSCT in CR, Percentage of patients undergoing alloSCT in MRD negativity, Disease Progression rate at 3, 6 and 12 months and at transplant, Molecular Disease Progression at 3, 6 and 12 months and at transplant, Overall Survival (OS), defined as the number of days between the first study drug administration and death from any cause or lost to follow up., Progression-Free Survival (PFS), defined as the number of days between the first study drug administration and any event including disease progression or death., Molecular Disease-Free Survival (MDFS), defined as the number of days between the data of response (MRD negativity) and molecular disease progression or death., Molecular progression-free survival (MPFS), defined as the number of days between the first study drug administration and molecular disease progression or death., Safety and toxicity of venetoclax-azacitidine in the experimental	—

Measure

Time frame

MRD negativity rate at 3 and 6 months and at transplant, Percentage of patients undergoing alloSCT in CR, Percentage of patients undergoing alloSCT in MRD negativity, Disease Progression rate at 3, 6 and 12 months and at transplant, Molecular Disease Progression at 3, 6 and 12 months and at transplant, Overall Survival (OS), defined as the number of days between the first study drug administration and death from any cause or lost to follow up., Progression-Free Survival (PFS), defined as the number of days between the first study drug administration and any event including disease progression or death., Molecular Disease-Free Survival (MDFS), defined as the number of days between the data of response (MRD negativity) and molecular disease progression or death., Molecular progression-free survival (MPFS), defined as the number of days between the first study drug administration and molecular disease progression or death., Safety and toxicity of venetoclax-azacitidine in the experimental

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Countries

Italy

Outcome results

None listed