Translate page

English English
en Englishbg Bulgarianzh-CN Chinese (Simplified)hr Croatiancs Czechda Danishnl Dutchfi Finnishfr Frenchde Germanel Greekiw Hebrewhi Hindiid Indonesianit Italianja Japaneseko Koreanmk Macedonianpl Polishpt Portuguesero Romanianru Russiansr Serbiansk Slovaksl Slovenianes Spanishsv Swedishth Thaitr Turkishvi Vietnamese

Overview of clinical trials in CML - Not yet recruiting trials

New CML compounds in development 

Source: www.clinicaltrials.gov
Last update: April 22, 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.

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

Disclaimer
The information provided in this overview is sourced from www.clinicaltrials.gov and is current as of April 22, 2025. The iCMLf is not responsible for any inaccuracies, changes, or outdated information that may appear at the time of viewing.
This list is intended as an informational resource and is organised alphabetically by sponsoring company. The iCMLf does not endorse any specific clinical trial, investigational drug, or sponsor listed.
For the most accurate and detailed information, including eligibility criteria, locations, and contact details, please refer directly to the study entry 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

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 Not yet recruiting
Estimated enrolment: 69 participants		 Rep. of Korea: Exact site information not available
 Asciminib RWE, NIS, Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL) (ASC4REAL)
(Clinicaltrials.gov Identifier: NCT06684964)

This non-interventional study aims to evaluate the real-world effectiveness, tolerability, adherence, healthcare resource utilization, and patient-reported outcomes of asciminib in Ph+ CML-CP patients previously treated with at least two TKIs in Saudi Arabia.

More information

 Novartis Pharmaceuticals Not yet recruiting
Estimated enrolment: 40 patients		 Saudi Arabia: 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. 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 Not yet recruiting
Estimated enrolment: 50 patients		 USA: 1
Olverembatinib (HQP1351)  

The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-BP
(Clinicaltrials.gov Identifier: NCT06390306)

This study aims to evaluate the efficacy and safety of third-generation TKIs combined with azacitidine and a Bcl-2 inhibitor in patients with myeloid blast-phase CML, while also conducting multi-omics analysis to identify potential outcome-related biomarkers.

More information

 		 Peking University People's Hospital Not yet recruiting
Estimated enrolment: 40 participants		 China: 1
Olverembatinib (HQP1351)  

PEDIATRIC CML STUDY

Olverembatinib Combined With Venetoclax and Azacitidine in Blast Phase Ph Chromosome-positive CML
(Clinicaltrials.gov Identifier: NCT06757855)

This study aims to evaluate the efficacy and safety of combining olverembatinib, venetoclax, and azacitidine for treating CML patients in the blast crisis phase, leveraging their synergistic effects to overcome TKI resistance and improve outcomes.

More information

 Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting
Estimated enrolment: 29 patients		 China:
Exact site information not available

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.		 Not yet recruiting
Estimated enrolment: 120 participants		 China: 5