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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: April 1, 2025

The iCMLf is providing this overview of clinical trials to support clinicians, patients, and patient advocates by bringing together information on current clinical trials for new compounds in CML — all in one place without needing to spend time searching. 

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.

No. Compound Brief description of the study Sponsor Status Location / Centres
1 Asciminib

Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation (ASC4INDIA)
(Clinicaltrials.gov Identifier: NCT06427811)

This Phase IV study aims to confirm the safety and efficacy of asciminib in Indian patients with Ph+ CML-CP, with and without the T315I mutation, following its approval by the Drugs Controller General of India.

More information

 Novartis Pharmaceuticals Not yet recruiting
Estimated enrolment: 85 participants

India: 
Exact site information not available
 2  Asciminib Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib. (ASC4TARGET)
(Clinicaltrial.gov Identifier: NCT06514534)

This Phase II study aims to evaluate the efficacy and safety of asciminib in managing CML-CP and CML-AP in patients with the T315I mutation, addressing a critical unmet need by exploring its potential as a new therapeutic option for those with limited treatment choices.

More information
 		 Novartis Pharmaceuticals Not yet recruiting
Estimated enrolment: 20 participants


No location data available
 3  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
 4 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
5   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
 6 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
7 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
 8 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
 9 Olverembatinib (HQP1351)  

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
 10

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