New CML compounds in development

Source: www.clinicaltrials.gov
Last update: April 24, 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 April 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
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 Contact details: novartis.email@novartis.com	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. 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
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 Contact details: jiangqian@medmail.com.cn	Not yet recruiting Estimated enrolment: 30 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 Contact details: weihui@ihcams.ac.cn	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. Contact details: jiangqian@medmail.com.cn	Not yet recruiting Estimated enrolment: 120 participants	China: 5

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