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 recruiting clinical trials focused on novel therapies — including study details, sponsors, estimated enrolment, locations and the number of study centres.
For an overview of clinical trials in CML not yet recruiting, click here.
No. | Compound | Brief description of the study | Sponsor | Status | Location / Centres |
1 | Asciminib |
Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia |
Novartis Pharmaceuticals | Recruiting Estimated enrolment: 34 participants |
USA: 6 |
2 | Asciminib |
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. |
Novartis Pharmaceuticals | Recruiting Estimated enrolment: 347 participants |
USA: 4 |
3 | Asciminib |
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (Clinicaltrials.gov Identifier: NCT06236724) 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 |
MD Anderson Cancer Center | Recruiting |
USA: 1 |
4 | Asciminib |
Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase (ALERTCML) (Clinicaltrials.gov Identifier: NCT05143840) |
Augusta University | Recruiting Estimated enrolment: 8 participants |
USA: 6 |
5 | Asciminib |
Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML |
Sir Mortimer B. Davis - Jewish General Hospital | Recruiting Estimated enrolment: 164 participants |
Canada: 4 |
6 | Asciminib |
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
|
Medical College of Wisconsin | Recruiting Estimated enrolment: 51 participants |
USA: 4 |
7 | Asciminib |
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia |
M.D. Anderson Cancer Center |
Recruiting |
USA: 1 |
8 | Asciminib |
Asciminib Prospective Non-Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France (ASSURE-3) |
Novartis Pharmaceuticals | Recruiting Estimated enrolment: 168 participants |
France: 38 |
9 | Asciminib |
Asciminib RMP Study |
Novartis Pharmaceuticals | Recruiting Estimated enrolment: 100 participants |
Rep. of Korea: 14 |
10 | 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. |
Marlise Luskin, MD, Dana-Farber Cancer Institute | Recruiting Estimated enrolment: 40 participants |
USA: 4 |
11 | ELVN-001 |
ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants (CML) |
Enliven Therapeutics | Recruiting Estimated enrolment: 21 participants |
Japan: 4 |
12 | ELVN-001 |
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (CML) |
Enliven Therapeutics | Recruiting Estimated enrolment: 180 participants |
USA: 3 |
13 | 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 |
Jiangsu Hansoh Pharmaceutical Co., Ltd. | Recruiting Estimated enrolment: 108 participants |
China: 1 |
14 | KRT232 |
KRT-232 and TKI Study in Chronic Myeloid Leukemia |
Kartos Therapeutics, Inc. | Recruiting Estimated enrolment: 109 participants |
USA: 5 |
15 | Olverembatinib (HQP1351) |
Study of Olverembatinib (HQP1351) in Patients With CP-CML (POLARIS-2) |
Ascentage Pharma Group Inc. | Recruiting Estimated enrolment: 285 participants |
USA: 1 |
16 | Olverembatinib (HQP1351) |
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL |
Ascentage Pharma Group Inc. | Recruiting Estimated enrolment: 62 participants |
USA: 8 |
17 | Olverembatinib (HQP1351) |
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia |
M.D. Anderson Cancer Center | Recruiting Estimated enrolment: 30 participants |
USA: 1 |
18 | Olverembatinib (HQP1351) |
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 |
Shenzhen Second People's Hospital | Recruiting Estimated enrolment: 40 participants |
China: 1 |
19 | Radotinib |
Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML |
Il-Yang Pharm. Co., Ltd. | Recruiting Estimated enrolment: 168 participants |
Rep. of Korea: 2 |
20 | Radotinib |
A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs |
Il-Yang Pharm. Co., Ltd. | Recruiting Estimated enrolment: 173 participants |
Rep. of Korea: 1 |
21 | 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 |
Terns, Inc. | Recruiting Estimated enrolment: 100 participants |
USA: 9 |
22 | TGRX-678 |
TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia |
Shenzhen TargetRx, Inc. | Recruiting Estimated enrolment: 90 participants |
USA: 2 |
23 | TGRX-678 |
TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients |
Shenzhen TargetRx, Inc. | Recruiting Estimated enrolment: 40 participants |
China: 1 |