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NCT03409081
Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or With FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
trial testing gilteritinib in Acute Myeloid Leukemia (AML). No longer available.
Quick facts
| Lead sponsor | Astellas Pharma Global Development, Inc. |
|---|---|
| Status | NO LONGER AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 6 locations across Italy, United Kingdom, Australia |
Drugs / interventions tested
- gilteritinib (GILTERITINIB) — full drug profile →
Conditions studied
- Acute Myeloid Leukemia (AML) — all drugs for Acute Myeloid Leukemia (AML) →
- FMS-like Tyrosine Kinase-3 (FLT3) Mutations — all drugs for FMS-like Tyrosine Kinase-3 (FLT3) Mutations →
Sponsor
Astellas Pharma Global Development, Inc. — full company profile →
Who can join
18 and older, any sex, with Acute Myeloid Leukemia (AML) or FMS-like Tyrosine Kinase-3 (FLT3) Mutations. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to provide expanded access to gilteritinib (ASP2215) for patients with FMS-like tyrosine kinase 3 (FLT3)-mutated relapsed or refractory acute myeloid leukemia (AML) or with FLT3-mutated AML in composite complete remission (CRc: \[complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission with incomplete platelet recovery (CRp)\]) with minimal residual disease (MRD) without access to comparable or alternative therapy.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results.
Dogu MH, Tekgunduz AIE, Deveci B, Korkmaz G, et al · · 2023 · cited 3× · PMID 37180209 · DOI 10.4084/mjhid.2023.031 -
PB1897: GILTERITINIB IN TURKEY: EARLY ACCESS PROGRAM RESULTS
Dogu M, Tekgunduz A, Deveci B, Korkmaz G, et al · · 2023
Verify or expand the search:
- PubMed search for NCT03409081
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of gilteritinib
Trials testing the same drug.
- NCT07140016 — A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) · Phase 1 · recruiting
- NCT04240002 — A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyr · Phase 1, PHASE2 · terminated
- NCT03730012 — A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like · Phase 1, PHASE2 · completed
- NCT03964038 — A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral · Phase 1 · completed
- NCT02997202 — A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Al · Phase 3 · completed
Other recruiting trials for Acute Myeloid Leukemia (AML)
Currently open trials in the same condition.
- NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
- NCT07500441 — Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML · recruiting
- NCT07410494 — Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06707493 — Ivosidenib as Post-HSCT Maintenance for AML · Phase 2 · recruiting
- NCT07458542 — Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia · active not recruiting
Other Astellas Pharma Global Development, Inc. trials
Trials by the same sponsor.
- NCT07488676 — A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07475806 — A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep · Phase 2 · recruiting
- NCT07425574 — A Study to Learn How Stargardt-type Eye Conditions Progress in Children and Adults · recruiting
- NCT07409272 — A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherap · Phase 3 · recruiting
- NCT07287995 — A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03409081 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Global Development, Inc.
- Last refreshed: 13 September 2018
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/NCT03409081.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing