Acute myeloid leukemia, NPM1-mutated

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Ashwin Kishtagari, MD
Vanderbilt University
Nashville, TN

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Martin W. Schoen, MD, MPH
Saint Louis University
St. Louis, MO

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Note: these are regimens tested in biomarker-specific populations for patients with NPM1-mutated AML, please see the main AML page for other regimens.

2 regimens on this page
3 variants on this page


Guidelines

"How I Treat"

Upfront induction therapy

Cytarabine & Etoposide

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (AMLSG 15-10) 2011-NR Phase 3 (C) ATRA, Cytarabine, Etoposide Not available

To be completed

Chemotherapy

References

  1. AMLSG 15-10: NCT01237808

ICE & ATRA

ICE & ATRA: Idarubicin, Cytarabine, Etoposide, All-Trans Retinoic Acid

Regimen variant #1, 60 or younger

Study Years of enrollment Evidence Comparator Comparative Efficacy
Schlenk et al. 2019 (AMLSG 09-09) 2010-2017 Phase 3 (C) ICE, ATRA, GO Did not meet primary endpoint of EFS

To be completed

Chemotherapy

  • Idarubicin (Idamycin) as follows:
    • Cycle 1: 12 mg/m2 IV once per day on days 1, 3, 5
    • Cycle 2: 12 mg/m2 IV once per day on days 1 & 3
  • Cytarabine (Ara-C) 100 mg/m2/day IV continuous infusion over 7 days, started on day 1 (total dose per cycle: 700 mg/m2)
  • Etoposide (Vepesid) as follows:
    • Cycle 1: 100 mg/m2 IV once per day on days 1 to 3
    • Cycle 2: 100 mg/m2 IV once per day on days 1 & 3

Targeted therapy

2 cycles

Subsequent treatment

Regimen variant #2, older than 60

Study Years of enrollment Evidence Comparator Comparative Efficacy
Schlenk et al. 2019 (AMLSG 09-09) 2010-2017 Phase 3 (C) ICE, ATRA, GO Did not meet primary endpoint of EFS

To be completed

Chemotherapy

Targeted therapy

2 cycles

Subsequent treatment

References

  1. AMLSG 09-09: Schlenk RF, Paschka P, Krzykalla J, Weber D, Kapp-Schwoerer S, Gaidzik VI, Leis C, Fiedler W, Kindler T, Schroeder T, Mayer K, Lübbert M, Wattad M, Götze K, Horst HA, Koller E, Wulf G, Schleicher J, Bentz M, Greil R, Hertenstein B, Krauter J, Martens U, Nachbaur D, Abu Samra M, Girschikofsky M, Basara N, Benner A, Thol F, Heuser M, Ganser A, Döhner K, Döhner H. Gemtuzumab Ozogamicin in NPM1-Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study. J Clin Oncol. 2020 Feb 20;38(6):623-632. Epub 2019 Dec 18. link to original article link to PMC article contains dosing details in manuscript PubMed NCT00893399