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Table 3 Recommended dose modifications within the VICTOR trial

From: 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

Standard of Care (DAGO) Arm

Observation

Recommended Modification

Serum creatinine (mmol/L)

Daunorubicin dose

 < 105

100%

105–265

75%

 > 265

50%

Bilirubin > 2 × ULN and AST/ALT > 2.5 × ULN

Postpone gemtuzumab ozogamicin dose until less than these levels. Consider omitting the scheduled dose if delayed more than 2 days between sequential infusions

Bilirubin (μmol/L)

Daunorubicin dose

 < 20

100%

20–50

75%

 > 50

50%

Bilirubin (μmol/L)

Cytarabine dose

 > 34

50%

Venetoclax and Low-dose Cytarabine Arm

During venetoclax maintenance:

Upon reoccurrence of grade 3 or 4 non-haematological toxicity, or grade 4 haematological toxicities, except lymphopenia

Dose at interruption (mg)

Restart dose (mg*)

400

300

300

200

200

100

100

50**

  1. * The modified dose should be continued for 1 week before increasing the dose
  2. ** As the venetoclax is only available in 100 mg strength, if a dose reduction to 50 mg is required, the patient should take 100 mg every other day
  3. ALT alanine aminotransferase, AST aspartate transaminase, ULN upper limit of normal