Difference between revisions of "Acute myeloid leukemia, NPM1-mutated"
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m (Text replacement - "style="background-color:#1a9851" |Phase III" to "style="background-color:#1a9851" |Phase 3") |
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|Awaiting publication (AMLSG 15-10) | |Awaiting publication (AMLSG 15-10) | ||
|2011-NR | |2011-NR | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[Stub#ATRA.2C_Cytarabine.2C_Etoposide|ATRA, Cytarabine, Etoposide]] | |[[Stub#ATRA.2C_Cytarabine.2C_Etoposide|ATRA, Cytarabine, Etoposide]] | ||
| style="background-color:#d3d3d3" |Not available | | style="background-color:#d3d3d3" |Not available | ||
| Line 58: | Line 58: | ||
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7030890/ Schlenk et al. 2019 (AMLSG 09-09)] | |[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7030890/ Schlenk et al. 2019 (AMLSG 09-09)] | ||
|2010-2017 | |2010-2017 | ||
| − | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|ICE, ATRA, GO | |ICE, ATRA, GO | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of EFS | | style="background-color:#ffffbf" |Did not meet primary endpoint of EFS | ||
Revision as of 02:19, 16 December 2021
Section editor transclusions Note: these are regimens tested in biomarker-specific populations for patients with NPM1-mutated AML, please see the main AML page for other regimens.
3 regimens on this page
4 variants on this page
|
Guidelines
"How I Treat"
- 2021: Falini et al. How I diagnose and treat NPM1-mutated AML
Upfront induction therapy
Cytarabine & Etoposide
| back to top |
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
- AMLSG 15-10: NCT01237808
ICE & ATRA
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ICE & ATRA: Idarubicin, Cytarabine, Etoposide, All-Trans Retinoic Acid
Regimen
| 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, 60 or younger: 12 mg/m2 IV once per day on days 1, 3, 5
- Cycle 2, 60 or younger: 12 mg/m2 IV once per day on days 1 & 3
- Cycles 1 & 2, older than 60: 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, 60 or younger: 100 mg/m2 IV once per day on days 1 to 3
- Cycle 2, 60 or younger: 100 mg/m2 IV once per day on days 1 & 3
- Cycles 1 & 2, older than 60: 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 verified protocol PubMed NCT00893399