A SAFETY RUN-IN AND PHASE 2, OPEN-LABEL, MULTICENTRE, STUDY INVESTIGATING SAFETY, TOLERABILITY AND EFFECTIVENESS OF VENETOCLAX ADD IN COMBINATION AT FLUDARABINE, CYRATABINE AND IDARUBICINE IN INDUCTION THERAPY OF NEW ONSET NON-M3 ACUTE MYELOID LEUKEMIA. V-FIRST - AML1718

Conditions

Acute Myeloid Leukemia

Brief summary

Primary end point is % of CR (CR + CRi + CRp) after course 1 or course 2 if course 2 is administered

Detailed description

Incidence time and nature of any adverse event., Severe effect related to treatment safety is defined as an adverse event occurring within the first cycle, judged to be related to treatment and meeting any of the following criteria: 1) Grade 3 non- hematological toxicity lasting more than 7 days 2) Grade 4 non- hematological toxicity., DLT as any grade 4 non-infective and non-hematologic adverse event that for the experience of the investigator cannot be due to FLAI chemotherapy alone and any grade 5 adverse event, Incidence, severity, seriousness and treatment-causality of Treatment Emergent Signs and Symptoms., Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, vital signs and 12-Lead ECG, TLS occurred during or after protocol or transplant procedures for up to 1 years., Description of patient-reported QoL over time

Related papers

No related papers found yet.

Interventions

DRUGFLUDARABINE PHOSPHATE

DRUGIDARUBICIN

DRUGVenclyxto 10 mg film-coated tablets

DRUGVenclyxto 100 mg film-coated tablets

DRUGCYTARABINE

DRUGVenclyxto 50 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary end point is % of CR (CR + CRi + CRp) after course 1 or course 2 if course 2 is administered	—

Secondary

Measure	Time frame
Incidence time and nature of any adverse event., Severe effect related to treatment safety is defined as an adverse event occurring within the first cycle, judged to be related to treatment and meeting any of the following criteria: 1) Grade 3 non- hematological toxicity lasting more than 7 days 2) Grade 4 non- hematological toxicity., DLT as any grade 4 non-infective and non-hematologic adverse event that for the experience of the investigator cannot be due to FLAI chemotherapy alone and any grade 5 adverse event, Incidence, severity, seriousness and treatment-causality of Treatment Emergent Signs and Symptoms., Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, vital signs and 12-Lead ECG, TLS occurred during or after protocol or transplant procedures for up to 1 years., Description of patient-reported QoL over time	—

Measure

Time frame

Incidence time and nature of any adverse event., Severe effect related to treatment safety is defined as an adverse event occurring within the first cycle, judged to be related to treatment and meeting any of the following criteria: 1) Grade 3 non- hematological toxicity lasting more than 7 days 2) Grade 4 non- hematological toxicity., DLT as any grade 4 non-infective and non-hematologic adverse event that for the experience of the investigator cannot be due to FLAI chemotherapy alone and any grade 5 adverse event, Incidence, severity, seriousness and treatment-causality of Treatment Emergent Signs and Symptoms., Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, vital signs and 12-Lead ECG, TLS occurred during or after protocol or transplant procedures for up to 1 years., Description of patient-reported QoL over time

—

Countries

Italy

Outcome results

None listed