Who is sponsoring NCT03942094?

NCT03942094 is sponsored by Shenzhen Second People's Hospital.

What drugs are being tested in NCT03942094?

Interventions in NCT03942094: Nilotinib.

What condition does NCT03942094 study?

NCT03942094 studies Chronic Myeloid Leukemia, Chronic Phase, Nilotinib.

Is NCT03942094 still recruiting?

NCT03942094 is currently status unknown. Last updated 16 March 2022.

Last reviewed 2022-03-16 · How we verify

NCT03942094

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

Nilotinib for First-line Newly Diagnosed CML-CP Patients

Status unknown Phase 3 Last updated 16 March 2022

What this trial tests

Phase 3 trial testing Nilotinib in Chronic Myeloid Leukemia, Chronic Phase in 100 participants. Status unknown.

Timeline

1 June 2019

Primary endpoint
1 June 2023

1 December 2023

Quick facts

Lead sponsor	Shenzhen Second People's Hospital
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 June 2019
Primary completion	1 June 2023
Estimated completion	1 December 2023
Sites	1 location across China

Drugs / interventions tested

Nilotinib (NILOTINIB) — full drug profile →

Conditions studied

Chronic Myeloid Leukemia, Chronic Phase — all drugs for Chronic Myeloid Leukemia, Chronic Phase →
Nilotinib — all drugs for Nilotinib →

Sponsor

Shenzhen Second People's Hospital

Who can join

18 and older, any sex, with Chronic Myeloid Leukemia, Chronic Phase or Nilotinib. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase IIIb, multi-centre, single-arm, open-label, prospective study investigating the efficacy and safety of nilotinib as the first-line treatment for the adult patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP) in China. Nilotinib 300 mg BID will be provided in this study. The assessment for the primary efficacy endpoint will be performed at 18 months and the rate of patients obtaining MR4.5 will be measured at this time point. Secondary endpoints include the complete hematologic response(CHR) and the rates of major molecular reactions (MMR) by 3, 6, 9,12,18 and 24 months; event free survival (EFS); overall survival (OS).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

18 months follow-up of deep molecular response 4.5 (MR<sup>4.5</sup>) with nilotinib in patients with newly diagnosed chronic-phase chronic myeloid leukemia: a prospective, multi-center study in China.
Wen B, Zhang Y, Lin H, Lou J, et al · · 2023 · PMID 38034530 · DOI 10.3389/fmed.2023.1267512

Verify or expand the search:

Other trials of Nilotinib

Trials testing the same drug.

NCT07493408 — Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of · Phase 2 · not yet recruiting
NCT05456191 — A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 · Phase 3 · active not recruiting
NCT05185947 — Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Ap · Phase 2 · active not recruiting
NCT04877522 — Asciminib Roll-over Study · Phase 4 · recruiting
NCT04971226 — A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP · Phase 3 · active not recruiting

Other recruiting trials for Chronic Myeloid Leukemia, Chronic Phase

Currently open trials in the same condition.

NCT06163430 — A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participa · Phase 1, PHASE2 · recruiting
NCT06368414 — A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia · Phase 2 · recruiting
NCT06119269 — Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase · recruiting
NCT06233890 — The Analysis of Fatigue on Tyrosine Kinase Inhibitor Therapy in Chronic Myeloid Leukaemia · active not recruiting
NCT03722420 — Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China) · Phase 3 · active not recruiting

Other Shenzhen Second People's Hospital trials

Trials by the same sponsor.

NCT06542016 — An Evaluation of the KCCQ Score in Predicting Cardiovascular Risk in Dialysis Patients · recruiting
NCT05540808 — The Value of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis · unknown
NCT05603975 — Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study · NA · unknown
NCT05465980 — Development and Validation of the Prediction Model for Cognitive Impairment · unknown
NCT05452759 — Research of Spiral Exhalation Device Oxygen Therapy to Improve the Treatment Effect of Patients With Severe Pneumonia · NA · unknown

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 NCT03942094 (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 Shenzhen Second People's Hospital
Last refreshed: 16 March 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/NCT03942094.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing