Evidence map›Paper›PMID 25766724›Full record

Trial reportBlood2015

Phase 3 study of nilotinib vs imatinib in Chinese patients with newly diagnosed chronic myeloid leukemia in chronic phase: ENESTchina.

Jianxiang Wang, Zhi-Xiang Shen, Giuseppe Saglio, Jie Jin, He Huang, Yu Hu, Xin Du, Jianyong Li, Fanyi Meng, Huanling Zhu and 10 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01275196 (ENESTChina), which is not on this map. Cited by 59 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 5 pooled it
10.3field-weighted citation impact, top 1% of its field
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.

NCT01275196 phase3completednot on this map

ENESTChina: A Phase III Multi-center, Open-label, Randomized Study of Nilotinib Versus Imatinib in Chinese Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2011 to 2014Enrolled267ConditionsChronic Myeloid LeukemiaArmsNilotinib, Imatinib
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 5 syntheses or guidelines pooled it, 108 citations in OpenAlex.

  1. [Guideline for the diagnosis and treatment of chronic myeloid leukemia in China (2025)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025
    Guideline
  2. Pooled it
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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

20 authors at 15 institutions in 3 countries.

Jianxiang WangState Key Laboratory of Experimental Hematology, Department of Clinical Hematology, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin, China;
Zhi-Xiang ShenShanghai Institute of Hematology, Shanghai Ruijin Hospital, Shanghai, China;
Giuseppe SaglioDepartment of Clinical and Biological Sciences, San Luigi Hospital, University of Turin, Orbassano, Italy;
Jie JinDepartment of Hematology, The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, Zhejiang Province, China;
He HuangDepartment of Hematology, The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, Zhejiang Province, China;
Yu HuInstitute of Hematology, Wuhan Union Hospital, Tongji Medical College, Wuhan Hubei, China;
Xin DuDepartment of Hematology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou Guangdong, China;
Jianyong LiDepartment of Hematology, Jiangsu Province People's Hospital, Nan Jing, China;
Fanyi MengDepartment of Hematology, Nanfang Hospital, Guangzhou Southern Medical University, Guangzhou Guangdong, China;
Huanling ZhuDepartment of Hematology, West China Hospital of Sichuan University, Chengdu Sichuan, China;
Jianda HuDepartment of Hematology, Fujian Medical University Union Hospital, Fuzhou, China;
Jianmin WangDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China;
Ming HouDepartment of Hematology, Qilu Hospital, Shandong University, Jinan, China;
Sabine HertleNovartis Pharma AG, Basel, Switzerland;
Hans D MenssenNovartis Pharma AG, Basel, Switzerland;
Christine-Elke OrtmannNovartis Pharma AG, Basel, Switzerland;
Catherine TribouleyNovartis Pharmaceuticals Corporation, East Hanover, NJ;
Ye YuanBeijing Novartis Pharma Company, Limited, Beijing, China;
Michele BaccaraniDepartment of Hematology-Oncology, and the Department of Experimental, Diagnostic, and Specialty Medicine, University of Bologna, Bologna, Italy; and.
Xiaojun HuangPeking University People's Hospital and Institute of Hematology, Beijing, China.
Novartis (Switzerland) · CHFirst Affiliated Hospital Zhejiang University · CNChanghai Hospital · CNFujian Medical University · CNGuangdong General Hospital · CNInstitute of Hematology & Blood Diseases Hospital · CNNovartis (China) · CNPeking University · CNQilu Hospital of Shandong University · CNShanghai Institute of Hematology · CNSichuan University · CNSouthern Medical University · CNUniversity of Bologna · ITUniversity of Turin · ITWuhan Union Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Treatment with a tyrosine kinase inhibitor (TKI) targeting BCR-ABL1 is currently the standard of care for patients with chronic myeloid leukemia (CML) in chronic phase (CML-CP). In this study, we present results of the ENESTchina (Evaluating Nilotinib Efficacy and Safety in Clinical Trials-China) that was conducted to investigate nilotinib 300 mg twice daily vs imatinib 400 mg once daily in a Chinese population. ENESTchina met its primary end point with a statistically significant higher rate of major molecular response (MMR; BCR-ABL1 ≤0.1% on the International Scale) at 12 months in the nilotinib arm vs the imatinib arm (52.2% vs 27.8%; P < .0001), and MMR rates remained higher with nilotinib vs imatinib throughout the follow-up period. Rates of complete cytogenetic response (0% Philadelphia chromosome-positive [Ph+] metaphases by standard cytogenetics) were comparable and ≥80% by 24 months in both arms. The estimated rate of freedom from progression to accelerated phase/blast crisis at 24 months was 95.4% in each arm. The safety profiles of both drugs were similar to those from previous studies. In conclusion, rates of MMR at 12 months were superior with nilotinib vs imatinib in Chinese patients with newly diagnosed Ph+ CML-CP. This trial was registered at www.clinicaltrials.gov as #NCT01275196.

Indexed as

AdolescentAdultAgedAntineoplastic AgentsBenzamidesChinaFemaleHumansImatinib MesylateLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-PhaseMaleMiddle AgedNeoadjuvant TherapyPiperazinesPyrimidinesAntineoplastic AgentsBenzamidesImatinib MesylatenilotinibPiperazinesPyrimidines

Identifiers

PMID25766724
PMCPMC4416528
OpenAlexW1997730029

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.