Table 1.
Selected ongoing and planned FLT3 inhibitor clinical trials
| Clinical trial | Status | Agents | Location | Web site |
|---|---|---|---|---|
| First-line chemotherapy combinations | ||||
| QuANTUM-First: Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) | Active | Cytarabine and daunorubicin/idarubicin; HiDAC/HSCT; quizartinib vs placebo | Multicenter, international | https://ClinicalTrials.gov/show/NCT02668653 |
| HOVON 156 AML: Phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by 1-year maintenance in patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations eligible for intensive chemotherapy | Planned | Cytarabine and daunorubicin; mitoxantrone + etoposide/HiDAC/HSCT; gilteritinib vs midostaurin | Multicenter, international | http://www.hovon.nl/studies/studies-per-ziektebeeld/aml.html?action=showstudie&studie_id=148&categorie_id=4 |
| Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML | Active | Cytarabine and daunorubicin; HiDAC/HSCT; crenolanib vs midostaurin | Multicenter | https://clinicaltrials.gov/ct2/show/NCT03258931 |
| HMA combinations | ||||
| LACEWING: A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy | Active | Gilteritinib vs gilteritinib + azacitidine vs azacitidine | Multicenter, international | https://ClinicalTrials.gov/show/NCT02752035 |
| Quizartinib and Decitabine in Treating Participants With Untreated or Relapsed FLT3-ITD Mutated Acute Myeloid Leukemia or Myelodysplastic Syndrome | Active | Decitabine + quizartinib | Single center | https://ClinicalTrials.gov/show/NCT03661307 |
| SC combinations | ||||
| Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML | Active | HAM or FLAG-Ida; crenolanib vs placebo | Multicenter, international | https://clinicaltrials.gov/ct2/show/NCT03250338 |
| Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With Acute Myeloid Leukemia (AML), High Risk Myelodysplastic Syndrome (HR MDS) or Myeloid Blast Phase of Chronic Myeloid Leukemia (CML) | Active | Cladribine, cytarabine, idarubicin, midostaurin | Single center | https://ClinicalTrials.gov/show/NCT02115295 |
| Novel combinations | ||||
| A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML) | Planned | Gilteritinib + atezolizumab (anti-PD-L1 monoclonal antibody) | Multicenter | https://ClinicalTrials.gov/show/NCT03730012 |
| A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia | Active | Venetoclax (BCL2 inhibitor) + gilteritinib | Multicenter | https://ClinicalTrials.gov/show/NCT03625505 |
| Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia | Active | Quizartinib + venetoclax (BCL2 inhibitor) | Single center | https://ClinicalTrials.gov/show/NCT03735875 |
| Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML) | Active | Quizartinib + milademetan (MDM2 inhibitor) | Multicenter | https://ClinicalTrials.gov/show/NCT03552029 |
| A Safety and Efficacy Study of LGH447 in Patients With Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS) | Active | LGH447 (Pim kinase inhibitor) + midostaurin | Multicenter, international | https://ClinicalTrials.gov/show/NCT02078609 |
| Maintenance post-HSCT | ||||
| BMT CTN 1506: A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML) | Active | Gilteritinib vs placebo | Multicenter, international | https://ClinicalTrials.gov/show/NCT02997202 |
| Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients | Active | Crenolanib | Single center | https://ClinicalTrials.gov/show/NCT02400255 |
| Maintenance postchemotherapy | ||||
| A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission | Active | Gilteritinib vs placebo | Multicenter, international | https://ClinicalTrials.gov/show/NCT02927262 |
FLAG-Ida, fludarabine, cytarabine, and granulocyte colony-stimulating factor with idarubicin; HAM, high-dose cytarabine and mitoxantrone; PD-L1, programmed death-ligand 1.