Who is sponsoring NCT05353205?

NCT05353205 is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd..

What drugs are being tested in NCT05353205?

Interventions in NCT05353205: Flumatinib mesylate tablets (400mg), Flumatinib mesylate tablets (600mg).

What condition does NCT05353205 study?

NCT05353205 studies CML, Chronic Phase.

Is NCT05353205 still recruiting?

NCT05353205 is currently status unknown. Last updated 29 April 2022.

Last reviewed 2022-04-29 · How we verify

NCT05353205

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of the Efficacy and Safety of Flumatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

Status unknown Phase 4 Last updated 29 April 2022

What this trial tests

Phase 4 trial testing Flumatinib mesylate tablets (400mg) in CML, Chronic Phase in 200 participants. Status unknown.

Timeline

23 November 2021

Primary endpoint
30 December 2022

30 September 2025

Quick facts

Lead sponsor	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	200
Start date	23 November 2021
Primary completion	30 December 2022
Estimated completion	30 September 2025
Sites	1 location across China

Drugs / interventions tested

Flumatinib mesylate tablets (400mg) — full drug profile →
Flumatinib mesylate tablets (600mg) — full drug profile →

Conditions studied

CML, Chronic Phase — all drugs for CML, Chronic Phase →

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 74, any sex, with CML, Chronic Phase. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It's a double-blind , randomized ,multi-center study. The purpose of this study is to explore the efficacy and safety of flumatinib 400mg once daily (QD) versus 600mg QD as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Exploring treatment decision-making in chronic myeloid leukemia in chronic phase.
Andorsky D, Kota V, Sweet K. · · 2024 · cited 4× · PMID 39011484 · DOI 10.3389/fonc.2024.1369246
Novel targeted therapies in chronic myeloid leukemia.
Ashaq MS, Zhou Q, Li Z, Zhao B. · · 2024 · cited 2× · PMID 41550150 · DOI 10.1016/j.pscia.2024.100052
Structure and Dynamics of the ABL1 Tyrosine Kinase and Its Important Role in Chronic Myeloid Leukemia.
Irgit A, Kamıs R, Sever B, Tuyun AF, et al · · 2025 · cited 2× · PMID 40346758 · DOI 10.1002/ardp.70005

Verify or expand the search:

Other recruiting trials for CML, Chronic Phase

Currently open trials in the same condition.

NCT05367700 — A Study of HS-10382 in Patients With Chronic Myeloid Leukemia. · Phase 1 · recruiting
NCT03459534 — A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs · Phase 3 · recruiting

Other Jiangsu Hansoh Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07468851 — A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radic · Phase 1, PHASE2 · not yet recruiting
NCT07483437 — A Study of HS-20136-2 in Healthy Participants · Phase 1 · not yet recruiting
NCT07535970 — A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Part · Phase 1 · not yet recruiting
NCT07503015 — Phase 1 Study of HS-20152 in Healthy Participants · Phase 1 · not yet recruiting
NCT07414953 — A Phase Ib Study of HS-10504 Combined Therapy in NSCLC · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05353205 (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 Jiangsu Hansoh Pharmaceutical Co., Ltd.
Last refreshed: 29 April 2022

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/NCT05353205.

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