Acute myeloid leukemia, NPM1-mutated
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| Page editor | Section editor | ||
|---|---|---|---|
 |
Ashwin Kishtagari, MD Vanderbilt University Nashville, TN |
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Martin W. Schoen, MD, MPH Saint Louis University St. Louis, MO |
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"
- 2021: Falini et al. How I diagnose and treat NPM1-mutated AML PubMed
Upfront induction therapy
Cytarabine & Etoposide
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Awaiting publication (AMLSG 15-10) | 2011-NR | Phase 3 (C) | ATRA, Cytarabine, Etoposide | Not available |
Chemotherapy
References
- AMLSG 15-10: Clinical Trial Registry
ICE & ATRA
ICE & ATRA: Idarubicin, Cytarabine, Etoposide, All-Trans Retinoic Acid
Regimen variant #1, 60 or younger
| Study | Dates 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 |
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
- All-trans retinoic acid (ATRA) 45 mg/m2/day PO on days 6 to 8, then 15 mg/m2/day PO on days 9 to 21
2 cycles
Subsequent treatment
- HiDAC & ATRA consolidation
Regimen variant #2, older than 60
| Study | Dates 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 |
Chemotherapy
- Idarubicin (Idamycin) 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) 100 mg/m2 IV once per day on days 1 & 3
Targeted therapy
- All-trans retinoic acid (ATRA) 45 mg/m2/day PO on days 6 to 8, then 15 mg/m2/day PO on days 9 to 21
2 cycles
Subsequent treatment
- HiDAC & ATRA consolidation
References
- 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 Clinical Trial Registry