VICTOR: Venetoclax or Intensive Chemotherapy for Treatment Of Favourable Risk Acute Myeloid Leukaemia: a molecularly guided phase 2 study

Conditions

Acute Myeloid Leukaemia

Brief summary

Molecular event-free survival time (mEFS). An event is defined as follows: a) Failure to achieve morphological CR or CRi after two cycles of therapy, b) Molecular persistence, progression or relapse requiring treatment change (at any time), c) Morphological relapse (at any time) or d) Death (at any time)

Detailed description

Occurrence of morphological complete remission (CR or CRi) by the end of the second cycle of treatment (see protocol section 8.14 for definitions of morphological response), Death within 30 and 60 days from trial entry, Overall survival time, Time to morphological relapse (see protocol section 8.14 for definitions of morphological response), Time to molecular relapse (see protocol section 8.14 for definitions of molecular response), Cumulative occurrence of grade 3 and 4 adverse events at 12 and 24 months, Prevalence of molecular complete remission at month 3, 6 and 12, Cumulative resource use at 12 and 24 months including hospital admission days, blood product usage and days on intravenous antibiotics and antifungals, Health-related quality of life at month 3, 6, 12, 18 and 24, Change in performance status from baseline at month 3, 6, 12, 18 and 24, Change in Comprehensive Geriatric Assessment (CGA) from baseline at month 12 and 24

Related papers

No related papers found yet.

Interventions

DRUGVenetoclax

DRUGDAUNORUBICIN HYDROCHLORIDE

DRUGCYTARABINE

DRUGGEMTUZUMAB OZOGAMICIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Molecular event-free survival time (mEFS). An event is defined as follows: a) Failure to achieve morphological CR or CRi after two cycles of therapy, b) Molecular persistence, progression or relapse requiring treatment change (at any time), c) Morphological relapse (at any time) or d) Death (at any time)	—

Secondary

Measure	Time frame
Occurrence of morphological complete remission (CR or CRi) by the end of the second cycle of treatment (see protocol section 8.14 for definitions of morphological response), Death within 30 and 60 days from trial entry, Overall survival time, Time to morphological relapse (see protocol section 8.14 for definitions of morphological response), Time to molecular relapse (see protocol section 8.14 for definitions of molecular response), Cumulative occurrence of grade 3 and 4 adverse events at 12 and 24 months, Prevalence of molecular complete remission at month 3, 6 and 12, Cumulative resource use at 12 and 24 months including hospital admission days, blood product usage and days on intravenous antibiotics and antifungals, Health-related quality of life at month 3, 6, 12, 18 and 24, Change in performance status from baseline at month 3, 6, 12, 18 and 24, Change in Comprehensive Geriatric Assessment (CGA) from baseline at month 12 and 24	—

Measure

Time frame

Occurrence of morphological complete remission (CR or CRi) by the end of the second cycle of treatment (see protocol section 8.14 for definitions of morphological response), Death within 30 and 60 days from trial entry, Overall survival time, Time to morphological relapse (see protocol section 8.14 for definitions of morphological response), Time to molecular relapse (see protocol section 8.14 for definitions of molecular response), Cumulative occurrence of grade 3 and 4 adverse events at 12 and 24 months, Prevalence of molecular complete remission at month 3, 6 and 12, Cumulative resource use at 12 and 24 months including hospital admission days, blood product usage and days on intravenous antibiotics and antifungals, Health-related quality of life at month 3, 6, 12, 18 and 24, Change in performance status from baseline at month 3, 6, 12, 18 and 24, Change in Comprehensive Geriatric Assessment (CGA) from baseline at month 12 and 24

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Countries

Denmark

Outcome results

None listed