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Overview of clinical trials in CML - Not yet recruiting trials

New CML compounds in development 

Source: www.clinicaltrials.gov
Last update: June 13, 2025

On this page, you'll find a regularly updated list of not yet recruiting clinical trials focused on novel therapies — including study details, sponsors, estimated enrolment, locations and the number of study centres.

A downloadable searchable Excel file to filter by sponsor, compound, or trial phase
(Updated regularly; the current file is from Juni 2025)

For an overview of currently recruiting clinical trials in CML, click here.

Disclaimer
The information presented in this overview has been sourced from www.clinicaltrials.gov and reflects data available as of April 24, 2025. While the iCMLf strives to ensure accuracy, it is not responsible for any errors, updates, or changes that may have occurred since that date. This list is provided solely for informational purposes and is organized alphabetically by investigational compound. The iCMLf does not endorse or recommend any specific clinical trial, investigational drug, or sponsor mentioned. For the most current and comprehensive details - including eligibility criteria, study locations, and contact information - please consult the official listing on clinicaltrials.gov.

Compound Brief description of the study Sponsor Status Location / Centres
 Asciminib  

PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML (PEARL)
(Clinicaltrials.gov Identifier: NCT06409936)


This Phase 2 randomized study aims to evaluate the efficacy and safety of asciminib alone or in combination with nilotinib in newly diagnosed chronic-phase CML patients, assessing deep molecular response, treatment continuation, and treatment-free remission over five years.

More information


 Gruppo Italiano Malattie EMatologiche dell'Adulto

Contact details: 
p.fazi@gimema.it

Not yet recruiting
Estimated enrolment: 160 participants

 Italy: 
Exact site information not available
Asciminib   

A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia 
(AsterA)
(Clinicaltrials.gov Identifier: NCT06368414)

This study aims to evaluate the efficacy of adding asciminib to tyrosine kinase inhibitors (TKIs) in achieving treatment-free remission (TFR) for chronic-phase CML patients who previously failed a TKI cessation study.

More information

 		 Korean Society of Hematology

Contact details: 
ksh.cml.wp@gmail.com		 Not yet recruiting
Estimated enrolment: 69 participants		 Rep. of Korea: Exact site information not available
HS-10382  

Study of HS-10382 Combination in Patients With Chronic Myeloid Leukemia (CML)
(Clinicaltrials.gov Identifier: NCT06530810)

This study aims to evaluate the safety and tolerability of HS-10382, an oral allosteric BCR-ABL1 inhibitor, in combination therapy for patients with chronic myeloid leukemia (CML).

More information

 		 Jiangsu Hansoh Pharmaceutical Co., Ltd.

Contact details: 
dr_huyu@126.com		 Not yet recruiting
Estimated enrolment: 100 participants		 China:
Exact site information not available
Olverembatinib (HQP1351)  

Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in 
Chronic Phase
(Clinicaltrials.gov Identifier: NCT06817720)

This study aims to evaluate the efficacy, safety, and impact on quality of life of olverembatinib monotherapy in controlling newly diagnosed chronic-phase CML, with a primary focus on achieving major molecular response (MMR) by 12 months.

More information

 		 MD Anderson Cancer Center

Contact details: 
fhaddad@mdanderson.org		 Not yet recruiting
Estimated enrolment: 50 patients		 USA: 1

TQB3911

A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia
(Clinicaltrials.gov Identifier: NCT06672263)

Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.

More information

 Chia Tai 
Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Contact details: 
jiangqian@medmail.com.cn		 Not yet recruiting
Estimated enrolment: 120 participants		 China: 5