Venetoclax combined with low dose cytarabine compared to standard of care intensive chemotherapy for the treatment of favourable risk adult acute myeloid leukaemia (VICTOR): Study protocol for an international, open-label, multicentre, molecularly-guided randomised, phase II trial

Table 2 Permitted treatment schedules within the VICTOR trial

Drug	Dose	Method	Day of Cycle
Standard of Care (DAGO) Arm *
Cycle 1 (inpatient or ambulatory care setting) **
Daunorubicin	60 mg/m²	1 h IV infusion	1, 3, 5
Cytarabine	100 mg/m² (total 20 doses)	12-hourly by IV push	1–10
Gemtuzumab ozogamicin	3 mg/m² (capped at 5 mg^#)	2-h IV Infusion	1, 4 (or 4, 7)†
Cycle 2 (inpatient or ambulatory care setting) **
Daunorubicin	50 mg/m²	1 h IV infusion	1, 3, 5
Cytarabine	100 mg/m² (total 16 doses)	12-hourly by IV push	1–8
Cycles 3 and 4 (may be given as outpatient, ambulatory care setting or inpatient, as per local practice)
Cytarabine
< 60 years	3 g/m² twice a day	12-hourly by IV push	1, 3, 5
60–69 years	1.5 g/m² twice a day	12-hourly by IV push	1, 3, 5
≥ 70 years	1 g/m² once daily	12-hourly by IV push	1–5
Venetoclax and Low-dose Cytarabine Arm
Cycle 1 (inpatient^α)
Cytarabine	20 mg/m²	Subcutaneous^β	1–10
Venetoclax	100 mg	Oral	1
	200 mg	Oral	2
	400 mg	Oral	3
	100 mg	Oral	4–28
Cycles 2–4 (outpatient (up to 12 cycles may be given))
Cytarabine	20 mg/m²	Subcutaneous^β	1–10
Venetoclax^γ
Either	100 mg	Oral	1–28
Or	600 mg	Oral	1–28
Accompanying supportive care (one of the following is mandated during all cycles):
Aciclovir	400 mg twice a day	Oral	1–28
Valaciclovir	500 mg once a day	Oral	1–28
Posaconazole	300 mg twice a day	Oral	4
	300 mg once a day		5–28
Voriconazole	400 mg twice a day	Oral	4
	200 mg twice a day		5–28
Optional supportive care (one of the following is permitted):
Ciprofloxacin	500 mg twice a day		1–28
Levofloxacin	500 mg once a day		1–28

^* May be administered as per local practice
^** If current standard of care is treatment in ambulatory care setting or outpatient day unit, this is permitted at the discretion of the treating investigator
^# Unless local standard practice is to dose cap at 4.5 mg
^† Gemtuzumab ozogamicin (GO) should be given on days 4 and 7 if white blood cell count ≥ 30 × 10⁹/L on day 1. For New Zealand sites standard of care will consistent of daunorubicin and cytarabine only until GO is available for use
^α Patients should generally be admitted to hospital for cycle 1 of treatment unless there are established local protocols for ambulatory management of induction therapy
^β Method of administration may be as per local practice, including self-administration
^γ 100 mg dose used if patient remains on anti-infective prophylaxis, 600 mg if patients stop anti-infective prophylaxis

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