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AML2012 Overview

AML2012 Overview. Inv(16) and SR. HA 3 E. FLA. AD(x)E. CR. BM d22*. R. BM **. HAM. HA3E. FLA. MEC. FLAD(x). No CR. SCT for HR. Salvage therapy. MEC. MEC. Cytarabine 200 mg/m 2 12h ci iv. Day 6-12. Mitoxantrone 5 mg/m 2 iv. Day 6-10 Inf 1 hour. Etoposide 150 mg/m 2 iv.

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AML2012 Overview

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  1. AML2012 Overview Inv(16) and SR HA3E FLA AD(x)E CR BM d22* R BM** HAM HA3E FLA MEC FLAD(x) No CR SCT for HR Salvage therapy

  2. MEC MEC Cytarabine200 mg/m2 12h ci iv Day 6-12 Mitoxantrone 5 mg/m2iv Day 6-10 Inf 1 hour Etoposide 150 mg/m2iv Day 1-5 Inf 2 hours Mtxit* Mtx it age-adjusted <1y 6 mg 1-<2y 8 mg 2-<3y 10 mg ≥ 3y 12 mg Day 1 2 3 4 5 6 7 8 9 10 11 12 Children < 1y or < 10kg Cytarabine 6.7 mg/kg Etoposide 5 mg/kg Mitoxantrone 0.17 mg/kg

  3. AD(x)E Cytarabine 100 mg/m2ci Day 1,2 Cytarabine 100 mg/m2iv Day 3-8, 30 min inf, every 12h (liposomaal) Daunorubicine 60 mg/m2iv Day 2,4,6 1 hour inf Etoposide 150 mg/m2iv Day 6,7,8 2 hour Mtxit Mtx it age-adjusted <1y 6 mg 1-<2y 8 mg 2-<3y 10 mg ≥ 3y 12 mg Day 1 2 3 4 5 6 7 8 Children < 1y or < 10kg Cytarabine 3.3 mg/kg Etoposide 5 mg/kg Daunoxome 2 mg/kg

  4. FLAD(x) Fludarabine30 mg/m2 iv (30min) Day 1-5 Cytarabine2000 mg/m2inf (3h) Day 1-5 4h after fludarabine (liposomaal)Daunorubicine 60 mg/m2 iv inf (1h) Day 2,4,6 immediately after fludarabine Mtxit Mtx it age-adjusted <1y 6 mg 1-<2y 8 mg 2-<3y 10 mg ≥ 3y 12 mg 2 3 6 Day 1 4 5 Children < 1y or < 10kg Cytarabine 67 mg/kg Fludarabine 1 mg/kg Daunoxome 2 mg/kg

  5. Overview of consolidation HA3E FLA Inv(16) HAM HA3E FLA Standard risk No donor High risk HAM SCT Note that SR patients with Inv(16) only receive two consolidation blocks

  6. HAM Cytarabine1000 mg/m2inf (2h) Day 1-3 every 12 hours Mitoxantrone10 mg/m2 iv inf (1 hour) Day 3,4,5 Mtx it Mtx it age-adjusted <1y 6 mg 1-<2y 8 mg 2-<3y 10 mg ≥ 3y 12 mg 2 3 Day 1 4 5 Children < 1y or < 10 kg Cytarabine 33 mg/kg Mitoxantrone 0.33 mg/kg

  7. HA3E Cytarabine3000 mg/m2inf (2h) Day 1-3 every 12 hours Etoposide 100 mg/m2inf (1h) Day 1-5 MTX it Mtx it age-adjusted <1y 6 mg 1-<2y 8 mg 2-<3y 10 mg ≥ 3y 12 mg 2 3 Day 1 4 5 Children < 1y or < 10 kg Cytarabine 67 mg/kg Fludarabine 1 mg/kg Daunoxome 2 mg/kg

  8. FLA Fludarabine30 mg/m2 iv (30min) Day 1-5 Cytarabine2000 mg/m2inf (3h) Day 1-5 4h after fludarabine Mtx it Mtx it age-adjusted <1y 6 mg 1-<2y 8 mg 2-<3y 10 mg ≥ 3y 12 mg 2 3 Day 1 4 5 Children < 1y or < 10kg Cytarabine 67 mg/kg Fludarabine 1 mg/kg Daunoxome 2 mg/kg

  9. Assign HR BM + MRD Day 22 after course 1 LC < 5% LC ≥ 5% LC ≥ 15% Flowsheet induction LC ≥ 5% Repeat BM + MRD weekly until recovery of ANC and platelets Start course 2 immediately LC < 5% Start course 2 on recovery after course 1 BM + MRD day after course 2 LC ≥ 5% Salvage therapy If very aplastic BM consider repeat BM – see protocol text LC < 5% LC ≥ 5% BM +MRD + HAM* On recovery after course 2 Repeat BM + MRD weekly until recovery of ANC and platelets LC < 5% LC < 5% and recovery start HAM LC ≥ 0.1% assign HR LC before HAM ≥ 0.1% assign HR Assign RD

  10. AML2012 Flow MRD sampling

  11. Induction MRD Diagnosis – MRD target search Start course one Day 22 – MRD all patients Good Response < 5% LC MRD repeated weekly Poor Response ≥ 5% LC Course 2 direct Start course two after regeneration Start course two MRD D22 MRD before consolidation Poor Response Off protocol Good Response MRD repeated weekly Standard risk patients MRD before course 5* High risk patients MRD before SCT Start consolidation after regeneration Standard risk patients MRD before course 5* High risk patients MRD before SCT

  12. Consolidation MRD High risk patients MRD before SCT Standard risk patients MRD before course 5 The exact number of MRD samples cannot be determined but it is expected that 3-4 samples per patient will be taken during induction

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