Difference between revisions of "Acute myeloid leukemia, FLT3-positive - null regimens"
Jump to navigation
Jump to search
m |
|||
| Line 49: | Line 49: | ||
| style="background-color:#d73027" |Inferior RFS | | style="background-color:#d73027" |Inferior RFS | ||
|- | |- | ||
| − | |[ | + | |[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc11095884/ Levis et al. 2024 (MORPHO)] |
| − | |2017- | + | |2017-08-17 to 2020-07-08 |
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[# | + | |[[#Gilteritinib_monotherapy_999|Gilteritinib]] |
| − | | style="background-color:# | + | | style="background-color:#fee08b" |Might have inferior RFS (primary endpoint)<br>RFS24: 69.9% vs 77.2%<br>(HR 1.47, 95% CI 0.995-2.18) |
| + | |- | ||
|} | |} | ||
<div class="toccolours" style="background-color:#cbd5e8"> | <div class="toccolours" style="background-color:#cbd5e8"> | ||
| Line 62: | Line 63: | ||
===References=== | ===References=== | ||
#'''SORMAIN:''' Burchert A, Bug G, Fritz LV, Finke J, Stelljes M, Röllig C, Wollmer E, Wäsch R, Bornhäuser M, Berg T, Lang F, Ehninger G, Serve H, Zeiser R, Wagner EM, Kröger N, Wolschke C, Schleuning M, Götze KS, Schmid C, Crysandt M, Eßeling E, Wolf D, Wang Y, Böhm A, Thiede C, Haferlach T, Michel C, Bethge W, Wündisch T, Brandts C, Harnisch S, Wittenberg M, Hoeffkes HG, Rospleszcz S, Burchardt A, Neubauer A, Brugger M, Strauch K, Schade-Brittinger C, Metzelder SK. Sorafenib Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia With ''FLT3''-Internal Tandem Duplication Mutation (SORMAIN). J Clin Oncol. 2020 Sep 10;38(26):2993-3002. Epub 2020 Jul 16. [https://doi.org/10.1200/jco.19.03345 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32673171/ PubMed] [https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-018539-16/AT Link to clinical trial registration] DRKS00000591 | #'''SORMAIN:''' Burchert A, Bug G, Fritz LV, Finke J, Stelljes M, Röllig C, Wollmer E, Wäsch R, Bornhäuser M, Berg T, Lang F, Ehninger G, Serve H, Zeiser R, Wagner EM, Kröger N, Wolschke C, Schleuning M, Götze KS, Schmid C, Crysandt M, Eßeling E, Wolf D, Wang Y, Böhm A, Thiede C, Haferlach T, Michel C, Bethge W, Wündisch T, Brandts C, Harnisch S, Wittenberg M, Hoeffkes HG, Rospleszcz S, Burchardt A, Neubauer A, Brugger M, Strauch K, Schade-Brittinger C, Metzelder SK. Sorafenib Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia With ''FLT3''-Internal Tandem Duplication Mutation (SORMAIN). J Clin Oncol. 2020 Sep 10;38(26):2993-3002. Epub 2020 Jul 16. [https://doi.org/10.1200/jco.19.03345 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32673171/ PubMed] [https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-018539-16/AT Link to clinical trial registration] DRKS00000591 | ||
| − | #''' | + | #'''MORPHO:''' Levis MJ, Hamadani M, Logan B, Jones RJ, Singh AK, Litzow M, Wingard JR, Papadopoulos EB, Perl AE, Soiffer RJ, Ustun C, Ueda Oshima M, Uy GL, Waller EK, Vasu S, Solh M, Mishra A, Muffly L, Kim HJ, Mikesch JH, Najima Y, Onozawa M, Thomson K, Nagler A, Wei AH, Marcucci G, Geller NL, Hasabou N, Delgado D, Rosales M, Hill J, Gill SC, Nuthethi R, King D, Wittsack H, Mendizabal A, Devine SM, Horowitz MM, Chen YB; BMT-CTN 1506/MORPHO Study Investigators. Gilteritinib as Post-Transplant Maintenance for AML With Internal Tandem Duplication Mutation of FLT3. J Clin Oncol. 2024 May 20;42(15):1766-1775. Epub 2024 Mar 12. [https://doi.org/10.1200/jco.23.02474 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc11095884/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/38471061/ PubMed] [https://clinicaltrials.gov/study/NCT02997202 NCT02997202] |
[[Category:Acute myeloid leukemia regimens]] | [[Category:Acute myeloid leukemia regimens]] | ||
Revision as of 13:01, 30 May 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main FLT3+ AML page for regimens that include active anticancer treatment.
Maintenance after upfront therapy, including allogeneic HSCT
Observation
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Xuan et al. 2020 (Sorafenib-Flt3 AML-2015) | 2015-06-20 to 2018-07-21 | Phase 3 (C) | Sorafenib | Inferior 1-year cumulative incidence of relapse |
Preceding treatment
- Allogeneic stem cell transplant consolidation
References
- Sorafenib-Flt3 AML-2015: Xuan L, Wang Y, Huang F, Fan Z, Xu Y, Sun J, Xu N, Deng L, Li X, Liang X, Luo X, Shi P, Liu H, Wang Z, Jiang L, Yu C, Zhou X, Lin R, Chen Y, Tu S, Huang X, Liu Q. Sorafenib maintenance in patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised phase 3 trial. Lancet Oncol. 2020 Sep;21(9):1201-1212. Epub 2020 Aug 10. link to original article PubMed NCT02474290
- Update: Xuan L, Wang Y, Yang K, Shao R, Huang F, Fan Z, Chi P, Xu Y, Xu N, Deng L, Li X, Liang X, Luo X, Shi P, Liu H, Wang Z, Jiang L, Lin R, Chen Y, Tu S, Zhang Y, Sun J, Huang X, Liu Q. Sorafenib maintenance after allogeneic haemopoietic stem-cell transplantation in patients with FLT3-ITD acute myeloid leukaemia: long-term follow-up of an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2023 Aug;10(8):e600-e611. Epub 2023 Jul 3. link to original article PubMed
Placebo
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Burchert et al. 2020 (SORMAIN) | 2010-2016 | Phase 3 (C) | Sorafenib | Inferior RFS |
| Levis et al. 2024 (MORPHO) | 2017-08-17 to 2020-07-08 | Phase 3 (C) | Gilteritinib | Might have inferior RFS (primary endpoint) RFS24: 69.9% vs 77.2% (HR 1.47, 95% CI 0.995-2.18) |
Preceding treatment
- Allogeneic stem cell transplant consolidation
References
- SORMAIN: Burchert A, Bug G, Fritz LV, Finke J, Stelljes M, Röllig C, Wollmer E, Wäsch R, Bornhäuser M, Berg T, Lang F, Ehninger G, Serve H, Zeiser R, Wagner EM, Kröger N, Wolschke C, Schleuning M, Götze KS, Schmid C, Crysandt M, Eßeling E, Wolf D, Wang Y, Böhm A, Thiede C, Haferlach T, Michel C, Bethge W, Wündisch T, Brandts C, Harnisch S, Wittenberg M, Hoeffkes HG, Rospleszcz S, Burchardt A, Neubauer A, Brugger M, Strauch K, Schade-Brittinger C, Metzelder SK. Sorafenib Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia With FLT3-Internal Tandem Duplication Mutation (SORMAIN). J Clin Oncol. 2020 Sep 10;38(26):2993-3002. Epub 2020 Jul 16. link to original article PubMed Link to clinical trial registration DRKS00000591
- MORPHO: Levis MJ, Hamadani M, Logan B, Jones RJ, Singh AK, Litzow M, Wingard JR, Papadopoulos EB, Perl AE, Soiffer RJ, Ustun C, Ueda Oshima M, Uy GL, Waller EK, Vasu S, Solh M, Mishra A, Muffly L, Kim HJ, Mikesch JH, Najima Y, Onozawa M, Thomson K, Nagler A, Wei AH, Marcucci G, Geller NL, Hasabou N, Delgado D, Rosales M, Hill J, Gill SC, Nuthethi R, King D, Wittsack H, Mendizabal A, Devine SM, Horowitz MM, Chen YB; BMT-CTN 1506/MORPHO Study Investigators. Gilteritinib as Post-Transplant Maintenance for AML With Internal Tandem Duplication Mutation of FLT3. J Clin Oncol. 2024 May 20;42(15):1766-1775. Epub 2024 Mar 12. link to original article link to PMC article PubMed NCT02997202