Evidence map›Paper›PMID 41521262›Full record

Trial reportAnnals of hematology2026

Long-term follow-up of predominantly Asian patients with relapsed/refractory FLT3-mutated acute myeloid leukemia in the phase 3 COMMODORE trial.

Bin Jiang, Jian Li, Ligen Liu, Xin Du, Hao Jiang, Jianda Hu, Xiaoxi Zeng, Taishi Sakatani, Masanori Kosako, Yaru Deng and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Annals of hematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03182244 (Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03182244 phase3active not recruitingnot on this map

Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

TypeinterventionalSponsorAstellas Pharma IncRan2017 to 2027Enrolled276ConditionsAML With FLT3 MutationArmsGilteritinib, Cytarabine, Mitoxantrone, Etoposide, G-CSF
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Bin JiangDepartment of Hematology, Peking University International Hospital, Beijing, China.
Jian LiDepartment of Hematology, Peking Union Medical College Hospital, Beijing, China.
Ligen LiuDepartment of Hematology, Tongren Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Xin DuDepartment of Hematology, Guangdong Provincial People's Hospital, Guangzhou, China.
Hao JiangDepartment of Hematology, Peking University People's Hospital, Beijing, China.ORCID http://orcid.org/0000-0002-1182-8132
Jianda HuFujian Institute of Hematology, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.
Xiaoxi ZengAstellas China Investment Co, Ltd., Beijing, China.
Taishi SakataniAstellas Pharma, Inc., Tokyo, Japan.ORCID http://orcid.org/0000-0001-9585-3855
Masanori KosakoAstellas Pharma, Inc., Tokyo, Japan.ORCID http://orcid.org/0000-0002-4981-9450
Yaru DengAstellas China Investment Co, Ltd., Beijing, China.
Vladimir IvanovPersonalized Medicine Center, Almazov National Medical Research Center, St. Petersburg, Russia.ORCID http://orcid.org/0000-0003-1536-9313
Sergey BondarenkoDepartment of Bone Marrow Transplantation of Adults, RM Gorbacheva Research Institute, Pavlov University, St. Petersburg, Russia.ORCID http://orcid.org/0000-0002-2446-8092
Lily Wong Lee LeeDepartment of Hematology, Queen Elizabeth Hospital, Kota Kinabalu, Sabah, Malaysia.
Archrob KhuhapinantDivision of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Elena MartynovaDepartment of Hematology and Chemotherapy, Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk, Russia.
Nahla HasabouAstellas Pharma, Inc., Northbrook, IL, USA.
Jamie Jung-Hee AnAstellas Pharma, Inc., Singapore, Singapore.
Jianxiang WangState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China. wangjx@ihcams.ac.cn.ORCID http://orcid.org/0000-0001-9437-9151

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To evaluate the long-term efficacy and safety of gilteritinib compared with salvage chemotherapy (SC) in patients with relapsed/refractory FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML). In the phase 3 COMMODORE (NCT03182244) trial, patients with relapsed/refractory FLT3-mutated AML from China, Russia, Singapore, Thailand, and Malaysia were randomized to gilteritinib (120 mg/day) or SC. The long-term follow-up included assessments every 3 months for a maximum of 3 years from the end-of-treatment visit. The primary endpoint was overall survival (OS). Secondary endpoints included event-free survival (EFS), complete remission (CR) rate, hematopoietic stem cell transplantation (HSCT) rate, and transfusion maintenance and conversion rates. Overall, 276 patients (gilteritinib, n = 137; SC, n = 139) completed the long-term follow-up. Most (88.0%) patients were Asian. The median (95% confidence interval [CI]) OS was longer with gilteritinib versus SC (10.3 [8.8, 12.7] vs 5.4 [4.1, 8.1] months, respectively; hazard ratio [HR; 95% CI], 0.612 [0.451, 0.832]), with a median follow-up of 34.6 months. The median (95% CI) EFS was longer with gilteritinib versus SC (2.1 [< 0.1, 3.2] vs 0.6 [0.2, 1.2] months, respectively; HR [95% CI], 0.589 [0.438, 0.792]). The CR rate was 20.4% and 11.5% in the gilteritinib and SC arms, respectively. During the entire study period, 22.6% and 7.9% of patients in the gilteritinib and SC arms underwent HSCT, respectively; 18.2% of patients in the gilteritinib arm received on-study HSCT. No new safety concerns were identified. Long-term gilteritinib treatment improved clinical outcomes compared with SC and was well-tolerated in a predominantly Asian population with relapsed/refractory FLT3-mutated AML.

Indexed as

Aniline Compoundsfms-Like Tyrosine Kinase 3Leukemia, Myeloid, AcuteMutationPyridazinesAdolescentAdultAgedAsian PeopleFemaleFollow-Up StudiesHematopoietic Stem Cell TransplantationHumansMaleMiddle AgedPyrazinesAniline CompoundsFLT3 protein, humanfms-Like Tyrosine Kinase 3gilteritinibPyrazinesPyridazinesAcute myeloid leukemiaClinical trialsFLT3GilteritinibPhase 3

Identifiers

PMID41521262
PMCPMC12791058

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.