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Association details:
| Biomarker: | FLT3-ITD mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | crenolanib (ARO-002) (FLT3 inhibitor, PDGFR α inhibitor, PDGFR β inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations
Excerpt:
...- Patients must have tested positive for FLT3-ITD and /or other FLT3 activating mutations within < 60 days of the screening period....
Trial ID:
Source:
Title:
A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
Excerpt:
...- Confirmed primary AML relapsed or refractory after prior therapy, AML secondary to antecedent chemotherapy or radiation therapy, or AML due to prior myelodysplastic syndrome (MDS)/ myeloproliferative neoplasm (MPN) as defined by WHO criteria with presence of either FLT3 ITD and/or other FLT3 activating mutations...
Trial ID:
More C2 evidence
Source:
Title:
A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations
Excerpt:
...Subjects must have tested positive for FLT3-ITD and/or other FLT3 activating mutations 5....
Trial ID:
Source:
Title:
Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
Excerpt:
...Presence of FLT3-ITD and/or D835 mutation(s) 3....
Trial ID:
Source:
Title:
A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia
Excerpt:
...Definitive evidence of a FLT3-ITD and/or FLT3-TKD (D835/I836) mutation at the time of enrollment 4....
Trial ID:
Less C2 evidence
Source:
Title:
Long-term results of a phase 2 trial of crenolanib combined with 7+3 chemotherapy in adults with newly diagnosed FLT3 mutant AML
Published date:
05/26/2022
Excerpt:
Crenolanib maintenance therapy was offered...33 (75%) pts had FLT3-ITD, 8 (18%) had TKD, and 3 (7%) had ITD and TKD mutations. 11 pts had concomitant NPM1/DNMT3A mutations...11 pts had concomitant NPM1/DNMT3A mutations...CRc rates > 80% were noted in pts ≤ 60 yo, FLT3-ITD mutations, concomitant FLT3/DMT3A/NPM1 mutations...Long-term outcomes of a phase 2 trial of crenolanib combined with 7+3 induction and consolidation in adults with newly diagnosed FLT3 mutant AML demonstrate high response rates (CRc 86%).
Secondary therapy:
cytarabine + daunorubicin; cytarabine
DOI:
10.1200/JCO.2022.40.16_suppl.7007
Trial ID:
