Difference between revisions of "Acute myeloid leukemia, NPM1-mutated"

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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
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|[https://www.clinicaltrials.gov/ct2/show/NCT01237808 Awaiting publication (AMLSG 15-10)]
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| style="background-color:#1a9851" |Phase 3 (C)
 
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===References===
 
===References===
#'''AMLSG 15-10:''' NCT01237808
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==ICE & ATRA {{#subobject:e82156|Regimen=1}}==
 
==ICE & ATRA {{#subobject:e82156|Regimen=1}}==
 
ICE & ATRA: '''<u>I</u>'''darubicin, '''<u>C</u>'''ytarabine, '''<u>E</u>'''toposide, '''<u>A</u>'''ll-'''<u>T</u>'''rans '''<u>R</u>'''etinoic '''<u>A</u>'''cid
 
ICE & ATRA: '''<u>I</u>'''darubicin, '''<u>C</u>'''ytarabine, '''<u>E</u>'''toposide, '''<u>A</u>'''ll-'''<u>T</u>'''rans '''<u>R</u>'''etinoic '''<u>A</u>'''cid
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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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7030890/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31851556/ PubMed] NCT00893399
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# '''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 dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31851556/ PubMed] [https://clinicaltrials.gov/ct2/show/NCT00893399 Clinical Trial Registry]
 
[[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 15:06, 31 May 2023

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"

Upfront induction therapy

Cytarabine & Etoposide

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
[https://clinicaltrials.gov/ct2/show/NCT01237808 Clinical Trial Registry Awaiting publication (AMLSG 15-10)] 2011-NR Phase 3 (C) ATRA, Cytarabine, Etoposide Not available

References

  1. 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

2 cycles

Subsequent treatment


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

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 Clinical Trial Registry