Adults 18 to 69, any sex, with Acute Myeloid Leukemia or FLT3-mutated Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1 Part: Maximum Tolerated Dose (MTD) of GilteritinibPrimary· Day 1 up to the end of Induction period cycle 1 (up to 42 days)
The MTD was defined as the highest dose of gilteritinib at which the posterior mean of the DLT incidence during Cycle 1 of induction therapy was estimated to be closest to 33%.
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
NA
Phase 1 Part: Recommended Expansion Dose (RED) of GilteritinibPrimary· Day 1 up to the end of Induction period cycle 1 (up to 42 days)
RED was the recommended dose used in Phase 2 of the study that was decided by the sponsor's responsible person by comprehensively assessing the data obtained from the study.
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
120
Phase 1 Part: Number of Participants With Dose Limiting Toxicities (DLTs) of GilteritinibPrimary· Day 1 up to the end of Consolidation Cycle 1 (approximately up to 4 months)
DLTs were defined as:
Any Grade ≥ 3 non-hematologic or extramedullary toxicity with the following exceptions:
* Anorexia or fatigue
* Grade 3 nausea and/or vomiting if participant did not require tube feeding or total parenteral nutrition, or diarrhea if the events did not require or prolong hospitalization that could be managed to grade ≤ 2 with standard antiemetic or antidiarrheal medications used at prescribed dose within 7 days of onset.
* Grade 3 mucositis that resolved to Grade ≤ 2 within 7 days of onset, fever with neutropenia, with or without infection, infection
* Grade 4 peripheral
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
0
Phase 1: Dose Expansion (DEx)
1
Phase 1 Part: Number of Participants With Treatment Emergent Adverse Events (TEAEs)Primary· From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years)
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE included both serious and non-serious AEs. TEAE for Phase 1 was defined as an AE observed after the date of first dose until 30 days after the last dose.
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
3
Phase 1: Dose Expansion (DEx)
10
Phase 2 Part: Complete Remission (CR) Rate: Induction PeriodPrimary· From the date of first dose up to the start of Consolidation (approximately up to 4 months)
Percentage of participants with CR was reported. CR was defined as a morphologically leukemia-free state at the post-baseline visit, having a neutrophil count of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3, bone marrow blasts \< 5%. No evidence of Auer rods and no evidence of extramedullary leukemia. The blast counts in peripheral blood was ≤ 2%.
Group
Value
95% CI
Phase 2: FLT3-mutated AML
50
40.4 – 59.6
Phase 1 Part: Maximum Concentration (Cmax) of Gilteritinib Concomitant With Induction and Consolidation ChemotherapySecondary· Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1
Cmax was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.
Induction Period
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
246
± 154
Phase 1: Dose Expansion (DEx)
132
± 27.5
Consolidation period
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
133
± NA
Phase 1: Dose Expansion (DEx)
73.5
± 17.5
Phase 1 Part: Time to Attain Cmax (Tmax) of Gilteritinib Concomitant With Induction and Consolidation ChemotherapySecondary· Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1
Tmax was derived from the PK samples collected.
Induction period
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
3.93
3.82 – 6.13
Phase 1: Dose Expansion (DEx)
5.77
3.83 – 9.77
Consolidation period
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
2.94
1.85 – 4.03
Phase 1: Dose Expansion (DEx)
4.32
3.90 – 9.70
Phase 1 Part: Area Under Plasma Concentration-time Curve From Time 0 to 24 (AUC24) of Gilteritinib Concomitant With Induction and Consolidation ChemotherapySecondary· Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1
AUC24 was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.
Induction period
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
3880
± 2530
Phase 1: Dose Expansion (DEx)
2210
± 567
Consolidation period
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
2110
± NA
Phase 1: Dose Expansion (DEx)
1160
± 204
Phase 1 Part: Area Under The Concentration-Time Curve From The Time Zero to The Last Measurable Concentration (AUClast) of Gilteritinib Concomitant With Induction and Consolidation ChemotherapySecondary· Induction period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 4 Consolidation period: Pre-dose, 1, 2, 4, 6, 10, and 24 hours post-dose on Cycle 1 Day 1
AUClast was derived from the PK samples collected. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.
Induction period
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
3830
± 2520
Phase 1: Dose Expansion (DEx)
2190
± 552
Consolidation period
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
2090
± NA
Phase 1: Dose Expansion (DEx)
1150
± 202
Phase 1 Part: Plasma Trough Concentration (Ctrough) of Gilteritinib Concomitant With Induction and Consolidation ChemotherapySecondary· Induction period: Pre-dose on Cycle 1 Day 8, 11, and 17 Consolidation period: Pre-dose on Cycle 1 Day 6 and 15
Ctrough is the plasma concentration prior to drug administration. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.
Induction period: Cycle 1 day 8
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
245
± 144
Phase 1: Dose Expansion (DEx)
245
± 77.7
Induction period: Cycle 1 day 11
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
283
± 183
Phase 1: Dose Expansion (DEx)
417
± 203
Induction period: Cycle 1 day 17
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
393
± 252
Phase 1: Dose Expansion (DEx)
455
± 143
Consolidation period: Cycle 1 day 6
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
194
± NA
Phase 1: Dose Expansion (DEx)
159
± 12.1
Consolidation period: Cycle 1 day 15
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
285
± NA
Phase 1: Dose Expansion (DEx)
171
± 154
Phase 1 Part: Plasma Trough Concentration of Cytarabine Concomitant With Gilteritinib With Induction and Consolidation PeriodSecondary· Induction period: Predose on Cycle 1 Day 1, 3, and 8 Consolidation period: Predose on Cycle 1 Day 2 and 6
Ctrough is the plasma concentration prior to drug administration. It was planned that standard deviation(SD) would only be calculated if there are more than 3 participants analyzed otherwise, SD was not calculated.
Induction period: Cycle 1 Day 1
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
0
± NA
Phase 1: Dose Expansion (DEx)
0
± NA
Induction period: Cycle 1 Day 3
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
34.9
± 14.5
Phase 1: Dose Expansion (DEx)
210
± 417
Induction period: Cycle 1 Day 8
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
58.8
± 8.67
Phase 1: Dose Expansion (DEx)
110
± 107
Consolidation period: Cycle 1 Day 2
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
4.87
± NA
Phase 1: Dose Expansion (DEx)
9.39
± 2.19
Consolidation period: Cycle 1 Day 6
Group
Value
95% CI
Phase 1: Dose Evaluation (DEv)
7.09
± NA
Phase 1: Dose Expansion (DEx)
11.8
± 1.91
Phase 2 Part: Plasma Trough Concentration of Gilteritinib Concomitant With Induction and Consolidation ChemotherapySecondary· Induction period : Predose on Cycle 1 Day 15 and 21 Consolidation period: Predose on Cycle 1 Day 8 and 15
Ctrough is the plasma concentration prior to drug administration.
Induction Period: Cycle 1 Day 15
Group
Value
95% CI
Phase 2: FLT3-mutated AML
522
± 331
Induction Period: Cycle 1 Day 21
Group
Value
95% CI
Phase 2: FLT3-mutated AML
647
± 518
Consolidation Period: Cycle 1 Day 8
Group
Value
95% CI
Phase 2: FLT3-mutated AML
244
± 152
Consolidation Period: Cycle 1 Day 15
Group
Value
95% CI
Phase 2: FLT3-mutated AML
375
± 249
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events: Phase 1: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.1 years) Phase 2: From the date of first dose up to 30 days after the last dose ( maximum duration up to approximately 4.4 years) All-cause mortality: From randomization up to approximately 9.4 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1: Dose Evaluation (DEv)
Serious: 2/3 (67%)
Deaths: 0/3
Phase 1: Dose Expansion (DEx)
Serious: 1/10 (10%)
Deaths: 0/10
Phase 2: FLT3-mutated AML
Serious: 45/84 (54%)
Deaths: 25/84
Serious adverse events (56 terms)
Reaction
System
Phase 1: Dose Evaluation (…
Phase 1: Dose Expansion (D…
Phase 2: FLT3-mutated AML
Pneumonia
Infections and infestations
—
—
—
Sepsis
Infections and infestations
—
—
—
Hepatic function abnormal
Hepatobiliary disorders
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
Pyrexia
General disorders
—
—
—
Cardiac failure
Cardiac disorders
—
—
—
Septic shock
Infections and infestations
—
—
—
Drug-induced liver injury
Hepatobiliary disorders
—
—
—
Alanine aminotransferase increased
Investigations
—
—
—
Chronic graft versus host disease
Immune system disorders
—
—
—
Pneumonia fungal
Infections and infestations
—
—
—
Renal impairment
Renal and urinary disorders
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
Myocardial infarction
Cardiac disorders
—
—
—
Stress cardiomyopathy
Cardiac disorders
—
—
—
Gastritis
Gastrointestinal disorders
—
—
—
Acute graft versus host disease
Immune system disorders
—
—
—
Graft versus host disease
Immune system disorders
—
—
—
Abdominal abscess
Infections and infestations
—
—
—
Appendicitis
Infections and infestations
—
—
—
Bacterial sepsis
Infections and infestations
—
—
—
Brain abscess
Infections and infestations
—
—
—
Diverticulitis
Infections and infestations
—
—
—
Klebsiella sepsis
Infections and infestations
—
—
—
Liver abscess
Infections and infestations
—
—
—
Other adverse events (110 terms — click to expand)
The purpose of phase 1 part in this study was to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction chemotherapy based on the status of the onset of dose-limiting toxicity (DLT) in newly diagnosed Acute Myeloid Leukemia (AML) subjects. Phase 1 part also evaluated safety and tolerability and characterized the pharmacokinetic (PK) parameters of ASP2215 concomitant with induction and consolidation chemotherapy as well as evaluated the PK parameters of cytarabine concomitant with ASP2215.
The purpose of phase 2 part was to evaluate efficacy of ASP2215 in combination with induction therapy. Phase 2 cohort also evaluated safety and characterized the PK parameters of ASP2215 in combination with induction and consolidation therapy followed by maintenance therapy in newly diagnosed FLT3-mutated AML subjects.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07032727 — Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Act
· Phase 2
· recruiting
NCT06734585 — Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant
· completed
NCT06561880 — The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation
· Phase 1, PHASE2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
Last refreshed: 2 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02310321.