This protocol applies to patients with core binding factor acute myeloid leukaemia (CBF-AML) — specifically those who are RUNX1-RUNX1T1-positive or CBFB-MYH11-positive — who are eligible for standard induction and consolidation chemotherapy.
Induction 1 comprised cytarabine, daunorubicin, and — for patients with CD33-positive blasts — gemtuzumab ozogamicin (7+3 ± GO). Remission assessment between day 14 and day 21 showed blast persistence: CR/CRi (fewer than 5% blasts in the bone marrow) was not achieved. This protocol defines the next step after that failure.
Patients with confirmed blast persistence after induction 1 proceed to a second induction cycle. Options include either repeating a similar chemotherapy backbone or switching to an intermediate-dose cytarabine‑based regimen. The complete regimen selection, sequencing, and all dosing details are available in the full protocol.
Achievement of complete remission or complete remission with incomplete count recovery (CR/CRi), defined as fewer than 5% blasts in the bone marrow — enabling progression to consolidation.
For CBF-AML, the authors recommend 7 days of cytarabine, 3 days of daunorubicin (7+3) and 1–3 days of gemtuzumab ozogamicin (GO) in induction 1: 7+3+GO [II, A].
Patients with ≥5% blasts in BM after induction 1 (blast persistence) should receive a second induction cycle, which may consist of the identical chemotherapy as induction 1 or of a regimen containing intermediate-dose cytarabine (IDAC), for example, FLAG-Ida [III, C].
As soon as patients achieve CR/CRi after 1 or 2 induction cycles, they should proceed to consolidation treatment [II, B].
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