109 completed, 24 terminated, 17 unknown, 9 active not recruiting. 83 Phase 2, 40 Phase 1, 32 Phase 3, 17 Phase 4, 3 Early Phase 1.
Follow nilotinib: new trials by email Literature Review of nilotinib trials Research Report on nilotinib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIs ELVN-001, TKI - Chronic Myeloid Leukemia (CML), Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive | Phase 3 | Not yet recruiting | Enliven Therapeutics | 450 | 2026-12-31 | 2026-10-29 |
| A Study of HS-10382 Versus Investigator-selected TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP HS-10382, Imatinib, Dasatinib - Chronic Myeloid Leukemia | Phase 3 | Not yet recruiting | Jiangsu Hansoh Pharmaceutical Co., Ltd. | 408 | 2026-12-01 | 2026-10-21 |
| Impact of Tyrosine Kinase Inhibitors on Glucose Level and Lipid Metabolism in Chronic Myeloid Leukemia Patients Tyrosine kinase Inhibitors (Imatinib & Nilotinib) - Chronic Myeloid Leukemia | Not yet recruiting | Assiut University | 75 | 2026-05-01 | 2026-02-18 | |
| Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML Asciminib add-on, Imatinib, Dasatinib - Ph+ Acute Lymphoblastic Leukemia (Ph+ALL), Blastic Transformation of Chronic Myeloid Leukemia | Phase 2 | Not yet recruiting | The University of Hong Kong | 45 | 2026-03-30 | 2026-03-25 |
| A Real-world Chronic Myelogenous Leukemia (CML) Patient Disease Registry to Describe Patient Experience and Clinical Outcomes Among Patients With CML Receiving Approved First or Second Line Tyrosine Kinase Inhibitor (TKI) Therapy TKIs - Chronic Myelogenous Leukemia - Chronic Phase | Recruiting | Novartis Pharmaceuticals | 1000 | 2025-12-17 | 2026-07-20 | |
| PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML Asciminib, Nilotinib - CML, Chronic Phase, Chronic Myeloid Leukemia, Chronic Phase | Phase 2 | Recruiting | Gruppo Italiano Malattie EMatologiche dell'Adulto | 160 | 2025-06-26 | 2025-07-08 |
| A Bioavailability Study of Nilotinib in Healthy, Adult, Human Subjects Under Fasted Conditions. XS003 (nilotinib), Tasigna (nilotinib) - Cancer | Phase 1 | Completed | Xspray Pharma AB | 128 | 2024-11-15 | 2025-08-22 |
| Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial Biopsy Procedure, Biospecimen Collection, Computed Tomography - Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 40 | 2023-07-14 | 2026-08-04 |
| Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial Alpelisib, Binimetinib, Biopsy Procedure - Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8 | Phase 2 | Recruiting | National Cancer Institute (NCI) | 2900 | 2023-04-07 | 2026-11-12 |
| 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) Asciminib, Nilotinib - Philadelphia Chromosome-Positive Chronic Myeloid Leukemia | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 568 | 2022-11-21 | 2026-08-26 |
| Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis Paclitaxel, Nilotinib, ECG - Gynecologic Cancer, Gynecologic Neoplasms | Phase 2 | Completed | National Cancer Institute (NCI) | 21 | 2022-10-13 | 2026-06-25 |
| Asciminib Roll-over Study Asciminib single agent, Imatinib, Nilotinib - Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive | Phase 4 | Recruiting | Novartis Pharmaceuticals | 347 | 2022-08-30 | 2026-11-09 |
| Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma Nilotinib 100mg, Nilotinib 200mg, Nilotinib 300mg - Metastatic Melanoma, BRAF Gene Mutation | Phase 1 | Recruiting | Rina Plattner | 30 | 2022-06-01 | 2026-02-13 |
| Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation Asciminib 40 MG, Asciminib 40 MG Twice Daily, Asciminib 80 MG daily - Chronic Phase Chronic Myelogenous Leukemia | Phase 2 | Recruiting | Medical College of Wisconsin | 51 | 2021-11-11 | 2026-08-25 |
| A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP Imatinib, Nilotinib, Bosutinib - Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 405 | 2021-10-06 | 2026-08-28 |
| KRT-232 and TKI Study in Chronic Myeloid Leukemia KRT-232, Dasatinib, Nilotinib - Chronic Myeloid Leukemia | Phase 1 / Phase 2 | Unknown | Kartos Therapeutics, Inc. | 109 | 2021-05-07 | 2022-03-21 |
| Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real World Population Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Withdrawal, Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Re-initiation - Chronic Myeloid Leukemia, Chronic Myeloid Leukemia, BCR/ABL-Positive, in Remission | Phase 2 | Active not recruiting | Baylor College of Medicine | 17 | 2020-12-22 | 2026-05-04 |
| Nilotinib in Preventing Paclitaxel-Induced Peripheral Neuropathy in Patients With Stage I-III Breast Cancer Nilotinib, Nilotinib Hydrochloride Monohydrate, Paclitaxel - Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8 | Phase 1 | Completed | Ohio State University Comprehensive Cancer Center | 11 | 2020-12-11 | 2025-06-29 |
| Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database Bosutinib, Imatinib, Nilotinib - Chronic Myeloid Leukaemia | Completed | Pfizer | 1484 | 2020-11-18 | 2023-10-27 | |
| Evaluating Efficacy and Safety of Flumatinib for Chronic Phase Chronic Myeloid Leukemia(CML-CP) Without Optimal Response (Warning,Failure) to Imatinib or Dasatinib Flumatinib, Nilotinib - CML-CP; Mutation;Suboptimal Response or Failure in TKI | Unknown | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | 200 | 2020-11-01 | 2023-08-01 |
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive (96) · Leukemia, Myeloid, Chronic-Phase (26) · Leukemia (21) · Gastrointestinal Stromal Tumors (15) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (15) · Blast Crisis (9) · Neoplasms (8) · Neoplasm Metastasis (6) · Philadelphia Chromosome (5) · Bone Marrow Diseases (4) · Bronchiolitis Obliterans Syndrome (4) · Leukemia, Myeloid (4) · Melanoma (4) · Myeloproliferative Disorders (4) · Hematologic Diseases (3)
Novartis Pharmaceuticals (68) · Gruppo Italiano Malattie EMatologiche dell'Adulto (6) · Georgetown University (5) · National Cancer Institute (NCI) (5) · M.D. Anderson Cancer Center (4) · Assiut University (3) · University Health Network, Toronto (3) · Asan Medical Center (2) · Assistance Publique - Hôpitaux de Paris (2) · Centre Leon Berard (2) · Fox Chase Cancer Center (2) · Fred Hutchinson Cancer Center (2) · Gustave Roussy, Cancer Campus, Grand Paris (2) · Hospices Civils de Lyon (2) · Mayo Clinic (2)
United States (69) · Italy (37) · France (36) · Germany (34) · South Korea (26) · Spain (26) · Canada (24) · United Kingdom (22) · Netherlands (21) · China (15) · Poland (15) · Austria (14) · Japan (14) · Russia (14) · Brazil (13)
Alice P Chen, M.D. (2) · Dong-Wook Kim, MD, PhD (2) · Ehab Atallah, MD (2) · Fernando L Pagan, MD (2) · Margaret von Mehren, MD (2) · Abhijit Guha (1) · Ali Bazarbachi, MD, PhD (1) · Amer Zeidan (1) · Andreas Hochhaus, Prof. Dr. med. (1) · Andreas Hochhaus, Prof. MD (1) · Andrew Grigg, MBBS, MD, FRACP, FRCPA (1) · Andrew J. Wagner, MD, PhD (1)
PMID 17715389, PMID 25361995, PMID 27434297, PMID 40680102, PMID 16775235, PMID 18048643, PMID 19695406, PMID 19822896, PMID 20110053, PMID 20525993, PMID 21098399, PMID 21456006, PMID 21467546, PMID 21478667, PMID 21508120, PMID 21856226, PMID 22207416, PMID 23065514, PMID 23109697, PMID 23502220, PMID 23547655, PMID 23620574, PMID 23666528, PMID 24057647, PMID 24335106, PMID 24472814, PMID 24532039, PMID 24589908, PMID 24948656, PMID 25256816, PMID 25387866, PMID 25695690, PMID 25766724, PMID 25882987, PMID 26002753, PMID 26113419, PMID 26283632, PMID 26343356, PMID 26687426, PMID 26871197, PMID 26993758, PMID 27006491, PMID 27349810, PMID 27470600, PMID 27771544, PMID 27890073, PMID 28042454, PMID 28289867, PMID 28298564, PMID 28327988
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