Difference between revisions of "Acute myeloid leukemia, NPM1-mutated"
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
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| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7030890/ Schlenk et al. 2019 (AMLSG 09-09)] |
|2010-2017 | |2010-2017 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7030890/ Schlenk et al. 2019 (AMLSG 09-09)] |
|2010-2017 | |2010-2017 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
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===References=== | ===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. [https://doi.org/10.1200/JCO.19.01406 link to original article] [ | + | # '''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. [https://doi.org/10.1200/JCO.19.01406 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7030890/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/31851556 PubMed] NCT00893399 |
[[Category:Acute myeloid leukemia regimens]] | [[Category:Acute myeloid leukemia regimens]] | ||
[[Category:Biomarker-specific pages]] | [[Category:Biomarker-specific pages]] | ||
[[Category:Acute leukemias]] | [[Category:Acute leukemias]] | ||
Revision as of 13:35, 29 July 2022
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
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
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
- 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 | 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) 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 verified protocol PubMed NCT00893399