Overview of clinical trials in CML - Recruiting trials
Source: www.clinicaltrials.gov | Last update: September 11, 2025
On this page, you'll find a regularly updated list of recruiting clinical trials focused on novel therapies - including study details, sponsors, estimated enrolment, locations and the number of study centres.
Download our searchable Excel file to filter by sponsor, compound, or trial phase
(Updated regularly; the current file is from June 2025)
For an overview of not yet 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.
Asciminib
PEDIATRIC CML STUDY:
Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia
This study aims to support the development of asciminib in pediatric patients (ages 1 to <18) previously treated with TKIs by extrapolating its efficacy from adult CML cases based on shared disease characteristics. More information
Clinicaltrials.gov Identifier: NCT04925479
Compound: Asciminib
Sponsor: Novartis Pharmaceuticals, novartis.email@novartis.com
Status: Recruiting (estimated enrolment: 44 participants)
Location (Centres): USA (9), China (4), France (4), Germany (3), Greece (1), Hungary (1), Italy (4), Japan (3), South Korea (2), Netherlands (1), Poland (1), Russia (2), Thailand (3), Turkey (2)
Asciminib Roll-over Study
This open-label, global roll-over study aims to assess the long-term safety of asciminib and provide continued treatment for patients who have completed a Novartis-sponsored asciminib study and are deemed to benefit from ongoing therapy. More information
Clinicaltrials.gov Identifier: NCT04877522
Compound: Asciminib
Sponsor: Novartis Pharmaceuticals, novartis.email@novartis.com
Status: Recruiting (estimated enrolment: 347 participants)
Location (Centres): USA (5), Argentina (2), Austria (2), Brazil (3), Bulgaria (1), Canada (1), China (12), Czechia (2), Denmark (1), France (6), Germany (4), Italy (3), Japan (1), South Korea (4), Lebanon (1), Malaysia (3), Mexico (1), Oman (1), Poland (4), Portugal (2), Romania (1), Russia (4), Saudi Arabia (1), Singapore (1), Spain (12), Taiwan (1), Türkiye (1), UK (2), Vietnam (2)
Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib. (ASC4TARGET)
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
Clinicaltrial.gov Identifier: NCT06514534
Compound: Asciminib
Sponsor: Novartis Pharmaceuticals, novartis.email@novartis.com
Status: Recruiting (estimated enrolment: 20 participants)
Location (Centres): France (2)
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
The study aims to evaluate the effectiveness and safety of asciminib in controlling chronic myeloid leukemia (CML) by assessing molecular and cytogenetic responses, treatment-free remission, survival outcomes, and adverse events over time. More information
Clinicaltrials.gov Identifier: NCT06236724
Compound: Asciminib
Sponsor: MD Anderson Cancer Center, ejabbour@mdanderson.org
Status: Recruiting (estimated enrolment: 50 participants)
Location (Centres): USA (1)
Asciminib as Initial Therapy for Patients with Chronic Myeloid Leukemia in Chronic Phase (ALERTCML)
This Phase 2, multicenter, open-label study aims to evaluate the efficacy and safety of asciminib as a frontline treatment for newly diagnosed chronic-phase CML, with response monitored via PCR and an option to add a low-dose TKI if needed after 24-36 months. More information
Clinicaltrials.gov Identifier: NCT05143840
Compound: Asciminib
Sponsor: Augusta University, jsonnenberg@augusta.edu
Status: Recruiting (estimated enrolment: 100 participants)
Location (Centres): USA (7)
Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Tyrosine Kinase Inhibitors (TKI) in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
This Phase II study aims to evaluate the outcomes of patients with chronic-phase chronic myeloid leukemia (CML) who previously attempted TKI discontinuation and resumed the same TKI upon relapse. More information
Clinicaltrials.gov Identifier: NCT04838041
Compound: Asciminib
Sponsor: Medical College of Wisconsin, cccto@mcw.edu
Status: Recruiting (estimated enrolment: 51 participants)
Location (Centres): USA (4)
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
This Phase 2 open-label study aims to evaluate the efficacy of asciminib in patients previously treated with one line of TKI therapy by assessing the rate of major molecular response (MMR) at 12 months. More information
Clinicaltrials.gov Identifier: NCT06629584
Compound: Asciminib
Sponsor: MD Anderson Cancer Center, gcissa@mdanderson.org
Status: Recruiting (estimated enrolment: 40 participants)
Location (Centres): USA (1)
Asciminib RMP Study
This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of asciminib in the real-world clinical setting in Korean chronic myeloid leukemia (CML) patients. More information
Clinicaltrials.gov Identifier: NCT05943522
Compound: Asciminib
Sponsor: Novartis Pharmaceuticals, novartis.email@novartis.com
Status: Recruiting (estimated enrolment: 100 participants)
Location (Centres): South Korea (14)
RWE, NIS, Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. (ASC4REAL)
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
Clinicaltrials.gov Identifier: NCT06684964
Compound: Asciminib
Sponsor: Novartis Pharmaceuticals, novartis.email@novartis.com
Status: Recruiting (estimated enrolment: 40 participants)
Location (Centres): Saudi Arabia (4)
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML (PEARL)
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
Clinicaltrials.gov Identifier: NCT06409936
Compound: Asciminib
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto, p.fazi@gimema.it
Status: Not yet recruiting (estimated enrolment: 160 participants)
Location (Centres): Spain (11)
Asciminib/Blinatumomab
ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
This study aims to evaluate the safety and efficacy of ABL001 in combination with dasatinib and prednisone as a potential treatment for BCR-ABL+ B-cell acute lymphoblastic leukemia (Ph+ ALL) and chronic myeloid leukemia in lymphoid blast crisis. More information
Clinicaltrials.gov Identifier: NCT03595917
Compound: Asciminib/Blinatumomab
Sponsor: Dana-Farber Cancer Institute, Marlise_Luskin@DFCI.
HARVARD.edu
Status: Recruiting (estimated enrolment: 40 participants)
Location (Centres): USA (4)
ELVN-001
ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants (CML)
This study aims to evaluate the safety, tolerability, and optimal dose of ELVN-001 in Japanese patients with chronic-phase CML, with or without T315I mutations, who have failed, are intolerant to, or are ineligible for at least two prior TKIs. More information
Clinicaltrials.gov Identifier: NCT06787144
Compound: ELVN-001
Sponsor: Enliven Therapeutics, ClinicalTrialInformation@cmic.co.jp
Status: Recruiting (estimated enrolment: 21 participants). Site recruitment closed.
Location (Centres): Japan (4)
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (CML)
This study aims to evaluate the safety, tolerability, and optimal dose of ELVN-001 in patients with CML, with or without T315I mutations, who are relapsed, refractory, or intolerant to TKIs. More information
Clinicaltrials.gov Identifier: NCT05304377
Compound: ELVN-001
Sponsor: Enliven Therapeutics, ELVN-001-101 @enliventherapeutics.com
Status: Recruiting (estimated enrolment: 200 participants). Site recruitment closed.
Location (Centres): USA (4), Australia (1), Belgium (3), Canada (1), France (5), Germany (7), Hungary (2), Israel (3), Italy (1), Poland (3), South Korea (1), Spain (4), UK (3)
HS-10382
A Study of HS-10382 in Patients With Chronic Myeloid Leukemia
This study aims to evaluate the safety, tolerability, pharmacokinetics, and anti-CML activity of HS-10382, an oral allosteric BCR-ABL1 inhibitor, in patients with chronic myeloid leukemia (CML). More information
Clinicaltrials.gov Identifier: NCT05367700
Compound: HS-10382
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. dr_huyu@126.com
Status: Recruiting (estimated enrolment: 108 participants).
Location (Centres): China (1)
Olverembatinib (HQP1351)
Study of Olverembatinib (HQP1351) in Patients With CP-CML (POLARIS-2)
This Phase 3 global multicenter study aims to evaluate the efficacy of olverembatinib in chronic-phase CML, comparing its MMR rate to bosutinib in patients without the T315I mutation and assessing its therapeutic benefits in those with the mutation. More information
Clinicaltrials.gov Identifier: NCT06423911
Compound: Olverembatinib (HQP1351)
Sponsor: Ascentage Pharma Group Inc. kate.shantz@ascentage.com
Status: Recruiting (estimated enrolment: 285 participants).
Location (Centres): USA (1)
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
This Phase 1b multi-center, open-label study aims to evaluate the pharmacokinetics and determine the recommended Phase 2 dose of HQP1351 in patients with CML (CP, AP, or BP) or Ph+ ALL who have experienced resistance or intolerance to prior TKIs. More information
Clinicaltrials.gov Identifier: NCT04260022
Compound: Olverembatinib (HQP1351)
Sponsor: Ascentage Pharma Group Inc. Bill.Garrett@ascentage.com
Status: Recruiting (estimated enrolment: 242 participants).
Location (Centres): USA (9)
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
This study aims to determine the recommended safe and biologically effective doses of lisaftoclax and olverembatinib in combination with decitabine for participants with advanced CML and Ph+ AML. More information
Clinicaltrials.gov Identifier: NCT06401603
Compound: Olverembatinib (HQP1351)
Sponsor: MD Anderson Cancer Center nshort@mdanderson.org
Status: Recruiting (estimated enrolment: 30 participants).
Location (Centres): USA (1)
Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs
This study aims to evaluate the efficacy and safety of olverembatinib in chronic-phase CML patients who are resistant or intolerant to at least two second-generation TKIs, with efficacy measured by major molecular response (MMR) at 12 months. More information
Clinicaltrials.gov Identifier: NCT05311943
Compound: Olverembatinib (HQP1351)
Sponsor: Shenzhen Second People's Hospital duxingz@medmail.com.cn
Status: Recruiting (estimated enrolment: 40 participants).
Location (Centres): China (1)
The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-BP
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
Clinicaltrials.gov Identifier: NCT06390306
Compound: Olverembatinib (HQP1351)
Sponsor: Peking University People's Hospital jiangqian@medmail.com.cn
Status: Recruiting (estimated enrolment: 30 participants).
Location (Centres): China (15)
Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
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
Clinicaltrials.gov Identifier: NCT06817720
Compound: Olverembatinib (HQP1351)
Sponsor: MD Anderson Cancer Center, fhaddad@mdanderson.org
Status: Not yet recruiting (estimated enrolment: 100 participants)
Location (Centres): United States (1)
PEDIATRIC CML STUDY:
Olverembatinib Combined With Venetoclax and Azacitidine in Blast Phase Ph Chromosome-positive CML
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
Clinicaltrials.gov Identifier: NCT06757855
Compound: Olverembatinib (HQP1351)
Sponsor: Institute of Hematology & Blood Diseases Hospital, China weihui@ihcams.ac.cn
Status: Recruiting (estimated enrolment: 29 participants).
Location (Centres): China (1)
Radotinib
Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML
This observational study aims to evaluate the efficacy and safety of radotinib dose reduction in Ph+ CML patients, with the primary outcome assessed by the MMR rate at 12 months. More information
Clinicaltrials.gov Identifier: NCT06665412
Compound: Radotinib
Sponsor: Il-Yang Pharm. Co., Ltd. nykim@ilyang.co.kr
Status: Recruiting (estimated enrolment: 168 participants).
Location (Centres): South Korea (2)
A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
This Phase III multinational, multicenter, single-arm study aims to evaluate the efficacy and safety of radotinib in chronic-phase Ph+ CML patients who have failed or are intolerant to previous TKI therapies, including Imatinib. More information
Clinicaltrials.gov Identifier: NCT03459534
Compound: Radotinib
Sponsor: Il-Yang Pharm. Co., Ltd. nykim@ilyang.co.kr
Status: Recruiting (estimated enrolment: 173 participants).
Location (Centres): South Korea (1), Russia (6), Türkiye (6), Ukraine (5)
TERN-701
CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
This study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of TERN-701, a selective allosteric BCR-ABL1 inhibitor, in previously treated CP-CML patients through dose escalation and expansion phases. More information
Clinicaltrials.gov Identifier: NCT06163430
Compound: TERN-701
Sponsor: Terns, Inc. clinicaltrials@ternspharma.com
Status: Recruiting (estimated enrolment: 180 participants). Still open for site recruitment.
Location (Centres): USA (22), Australia (3), France (6), Germany (7), Italy (3), New Zealand (2) South Korea (4), Spain (9), UK (2)
TGRX-678
TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia
This single-arm, open-label study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TGRX-678 in CML patients who have failed or are intolerant to TKI treatments. More information
Clinicaltrials.gov Identifier: NCT06088888
Compound: TGRX-678
Sponsor: Shenzhen TargetRx, Inc. xinyi.zhu@tjrbiosciences.com
Status: Recruiting (estimated enrolment: 90 participants).
Location (Centres): USA (2)
TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients
This single-arm, open-label study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TGRX-678 in CML patients who have failed or are intolerant to TKI treatments. More information
Clinicaltrials.gov Identifier: NCT06453902
Compound: TGRX-678
Sponsor: Shenzhen TargetRx, Inc. yingkun.lv@tjrbiosciences.com
Status: Recruiting (estimated enrolment: 40 participants).
Location (Centres): China (1)