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Association details:
| Biomarker: | FLT3 mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | azacitidine (DNA methylation inhibitor) |
| Regimen: | HAG (cytarabine + granulocyte-colony stimulating factor (GCSF) + Synribo (omacetaxine mepesuccinate)) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Study of experimental drug NMS-03592088 in combination with azacitidine in adult patients with blood malignancies Studio del farmaco sperimentale NMS-03592088 in combinazione con azacitidina in pazienti adulti con tumori maligni del sangue
Excerpt:
...Fase I:• Tossicità limitanti della dose (dose limiting toxicity, DLT) al primo ciclo;Fase II:• LMA con FLT3-mutato: Tasso di Remissione Completa Composita (CRc: CR +CRi), cioè Remissione Completa (CR)+ Remissione Completa con recupero ematologico incompleto (CRi), come determinato dagli Sperimentatori sulla base delle raccomandazioni European LeukemiaNet (ELN) del 2017.• LMMC: Tasso di Risposta Globale, cioè Risposta Completa (CR) + Remissione citogenetica completa (CCR) + Remissione Parziale (PR) + Risposta Midollare (MR) + Beneficio Clinico (CB) come definito dai criteri dell'International Working Group (IWG) specifici della malattia....
Trial ID:
Source:
Title:
Maintenance Low Dose 5'-Azacitidine Post T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndrome and Acute Myelogenous Leukemia With High Risk for Post-Transplant Relapse
Excerpt:
...- Acute myelogenous leukemia (AML) in first remission that required more than 1 cycle of treatment to achieve remission or with the following cytogenetic abnormalities: FLT3 mutation, deletion/monosomy of chromosome 5 or 7, MLL gene rearrangement, or more than or equal to 3 cytogenetics abnormalities....
Trial ID:
More C2 evidence
Source:
Title:
Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia
Excerpt:
...- Acute myeloid leukemia with t(8;21)(q22;q22); RUNX1-RUNXT1 as determined by the Ohio State University (OSU) Molecular Reference Laboratory, per Cancer and Leukemia Group B (CALGB) 20202; however patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of > 2, may be registered to CALGB 20202 and registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and core-binding factor (CBF) molecular screening results from CALGB 20202...
Trial ID:
Source:
Title:
Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)
Excerpt:
...- Induction Failure, relapsed disease or second or greater remission; patients in first complete remission that required more than 1 cycle of treatment to achieve the remission, or that have AML evolving from MDS, or that had the following abnormalities: FLT3 mutation, deletion of chromosome 5 or 7, MLL gene rearrangement, or more than or equal to 3 cytogenetics abnormalities....
Trial ID:
Source:
Title:
Phase II Study of 5-azacytidine Maintenance After Transplant for AML or MDS
Excerpt:
...- Fms-like tyrosine kinase 3 (FLT3) mutation...
Trial ID:
Less C2 evidence
Source:
Title:
2745 High Efficacy of Azacitidine Plus Hag in Acute Myeloid Leukemia: A Multi-Center, Phase 2 Clinical Trial
Published date:
11/03/2022
Excerpt:
Upon Aza+HAG treatment, we observed the high CR/CRi rate in ND patients with mutated BCOR (100%,7/7), KIT (100%,3/3), IDH1 (100%,7/7), NPM1 (93.3%,14/15), ASXL1 (88.9%,8/9), DNMT3A (80. 0%,16/20), RUNX1 (75.0%,6/8), FLT3 (71.4%,5/7), and TET2 (71.4%,10/14) (Fig. 1I). We further observed the clearance of mutated genes after the induction therapy and found the variant allele fraction (VAF) of mutants was dramatically reduced among the CR/CRi patients. Specifically, VAF change of FLT3 mutant from 3 of 4 available patients reduced to <0.01%, with the other one, decreased by 91.9% (Fig. 1J); 4 out of 6 patients with IDH1 mutant reduced to <0.01%, with the other two, decreased 67.6% and 35.9%, respectively (Fig. 1K); 5 out of 6 patients with ASXL1 mutant reduced to <0.01%, with the other one, decreased by 33.4% (Fig. 1L); and 10 out of 14 patients with NPM1 mutant reduced to <0.01%, respectively (Fig. 1M). This study demonstrated that the Aza+HAG regimen is a cost-effective first-line therapy with high efficacy and well tolerance for elderly/unfit AML, especially ND AML patients.
Secondary therapy:
G-CSF stimulant + cytarabine
DOI:
https://doi.org/10.1182/blood-2022-164649
Trial ID:
