TheraRadar
Landscape / Oncology
Data updated: Jun 28, 2026

CML Clinical Trial Landscape

CML is being studied across 398 clinical trials registered since 2008, with 121 programs currently active. The competitive pipeline includes 8 active Phase 3 trials, 79 active Phase 2 trials, and 32 active Phase 1 trials.

Top industry sponsors include Novartis, Shenzhen TargetRx Co., Ltd., Jiangsu Hansoh Pharmaceutical Co., Ltd..

Trial activity

121 active / 398 total since 2008
Active by phase 8 Ph3 / 44 79 Ph2 / 216 32 Ph1 / 115 2 Ph4 / 23

Sponsor activity

Who is running trials now — green active, blue completed, red failed/terminated.

Sorted by active Active Done Failed
Novartis 6 35 5
Shenzhen TargetRx Co., Ltd. 4 2 0
Jiangsu Hansoh Pharmaceutical Co., Ltd. 3 1 0
Ascentage Pharma Group Inc. 2 3 0
Enliven Therapeutics 2 0 0
Il-Yang Pharm. Co., Ltd. 2 0 0
Incyte Biosciences International Sàrl 1 0 0
Crossbow Therapeutics, Inc. 1 0 0
Ossium Health, Inc. 1 0 0
MacroGenics 1 0 0
Terns, Inc. 1 0 0
Orca Biosystems, Inc. 1 0 0
Otsuka Beijing Research Institute 1 0 0
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. 1 0 0
Kartos Therapeutics, Inc. 1 0 0

All 15 active CML sponsors

Unlock the remaining 7 sponsors with active / completed / failed counts — sortable and exportable.

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How the field has grown

New-trial starts peaked in 2018 (25 registered); 2025 saw 14. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (17 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.

New trials started by year

2016
21
2017
20
2018
25
2019
22
2020
19
2021
18
2022
17
2023
11
2024
20
2025
14
2026
11

TheraRadar.com

Median Phase 3 enrollment by start year

2016 (1)
125
2017 (3)
214
2018 (3)
173
2019 (2)
256
2020 (0)
0
2021 (3)
199
2022 (1)
568
2023 (2)
89
2024 (1)
285
2025 (0)
0
2026 (1)
180

TheraRadar.com

Full trial pipeline

Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.

NCT05753384 ACTIVE NOT RECRUITING
Discontinuation of TyrosIne Kinase Inhibitors (TKI) in Chronic Myeloid Leukemia (CML) and Impact on the Immune System
Poitiers University Hospital n=170
NCT04971226 ACTIVE NOT RECRUITING
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
Novartis Pharmaceuticals n=405
NCT07489755 NOT YET RECRUITING
TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients
Shenzhen TargetRx Co., Ltd. n=180
NCT03480360 ACTIVE NOT RECRUITING
Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression
Dartmouth-Hitchcock Medical Center n=21
NCT05456191 ACTIVE NOT RECRUITING
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
Novartis Pharmaceuticals n=568
NCT06423911 RECRUITING
Study of Olverembatinib (HQP1351) in Patients With CP-CML
Ascentage Pharma Group Inc. n=285
NCT03722420 ACTIVE NOT RECRUITING
Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)
Il-Yang Pharm. Co., Ltd. n=238
NCT03459534 RECRUITING
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. n=173
NCT01231412 COMPLETED
Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant
Fred Hutchinson Cancer Center n=174
NCT01366612 TERMINATED
Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation
Hackensack Meridian Health n=53
NCT04948333 COMPLETED
Asciminib Treatment Optimization in ≥ 3rd Line CML-CP
Novartis Pharmaceuticals n=199
NCT02730299 COMPLETED
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
Gamida Cell ltd n=125
NCT04666259 COMPLETED
Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
Novartis Pharmaceuticals n=56
NCT02201459 COMPLETED
Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients
Hospices Civils de Lyon n=200
NCT05413915 TERMINATED
Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML
Sarit Assouline n=8
NCT03106779 COMPLETED
Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
Novartis Pharmaceuticals n=233
NCT03746054 TERMINATED
Evaluation of a Cardiovascular Active Prevention in Chronic Myeloid Leukemia on the Cardiovascular Morbi-mortality
University Hospital, Angers n=80
NCT03959241 COMPLETED
TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801)
Medical College of Wisconsin n=431
NCT01428635 COMPLETED
Eltrombopag Olamine in Treating Thrombocytopenia in Patients With Chronic Myeloid Leukemia or Myelofibrosis Receiving Tyrosine Kinase Therapy
M.D. Anderson Cancer Center n=21
NCT01951885 COMPLETED
Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention
Case Comprehensive Cancer Center n=101
NCT01657604 COMPLETED
TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study
University of Jena n=717
NCT03117816 COMPLETED
ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission
Philipps University Marburg n=214
NCT02566395 COMPLETED
Stem Cell Transplantation From HLA Partially-Matched Related Donors for Patients With Hematologic Malignancies
Northwell Health n=10
NCT02627677 TERMINATED
A Study Comparing Ponatinib and Nilotinib in Participants With Chronic Myeloid Leukemia
Ariad Pharmaceuticals n=44
NCT01596114 COMPLETED
European Stop Tyrosine Kinase Inhibitor Study
European LeukemiaNet n=868
NCT01743989 COMPLETED
A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.
Novartis Pharmaceuticals n=620
NCT02707393 COMPLETED
Allogeneic Stem Cell Transplantation for Children With CML
St. Anna Kinderkrebsforschung n=13
NCT02115386 TERMINATED
Trial to Evaluate the Improvement of Chronic Low-grade AEs in Patients With Ph+ CML With Optimal Response to Imatinib When Switched to Nilotinib
Novartis Pharmaceuticals n=7
NCT02174445 TERMINATED
An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years
Prof. Dr. Nikolas von Bubnoff n=14
NCT01305200 COMPLETED
Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant
Children's Oncology Group n=226
NCT03079505 TERMINATED
Dasatinib Versus Nilotinib for Treatment Naïve Chronic Myeloid Leukemia
Hamad Medical Corporation n=10
NCT00574873 COMPLETED
Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
Pfizer n=502
NCT01535391 COMPLETED
Nilotinib in PH+, BCR-, ABL+ CML Patients
Gruppo Italiano Malattie EMatologiche dell'Adulto n=109
NCT01755325 SUSPENDED
Phase III Study of Compound Formula Realgar-Indigo Naturalis Plus Imatinib Versus Placebo Plus Imatinib in Adult CML-CP Patients With Ph+
Junmin Li n=680
NCT02204644 COMPLETED
The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML
Jiangsu Hansoh Pharmaceutical Co., Ltd. n=400
NCT01749111 TERMINATED
Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis
Hospital Israelita Albert Einstein n=3
NCT01126892 COMPLETED
A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Novartis Pharmaceuticals n=6
NCT00760877 COMPLETED
Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)
Novartis Pharmaceuticals n=207
NCT01275196 COMPLETED
Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients
Novartis Pharmaceuticals n=267
NCT01254188 COMPLETED
Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients
Novartis Pharmaceuticals n=421
NCT00802841 COMPLETED
Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib
Novartis Pharmaceuticals n=191
NCT01650805 TERMINATED
Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)
Ariad Pharmaceuticals n=307
NCT02103322 COMPLETED
Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions
Amneal Pharmaceuticals, LLC n=48
NCT00799461 COMPLETED
Internet-Based Program With or Without Telephone-Based Problem-Solving Training in Helping Long-Term Survivors of Hematopoietic Stem Cell Transplant Cope With Late Complications
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium n=1,337

Full CML Pipeline

Every trial across Phase 1–4, plus enrollment analytics. Sortable, filterable, exportable.

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Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only