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Home › Medications › nilotinib

nilotinib

3 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials of nilotinib

36 trials tracked of nilotinib: 16 in phase 3 or 4 and 4 with published results. The most-cited published study has 98 citations.

36Trials tracked
16Phase 3 & 4
0Recruiting
4With published results
Phase distribution
Phase 4 7 Phase 3 9 Phase 2 17 Phase 1 2 Other / NA 1
  1. Phase 3 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) Completed · 98 cited
  2. Phase 4 An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment Completed · 36 cited
  3. Phase 4 Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase Completed · 32 cited
  4. Phase 3 A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML. Completed · 1 cited
  5. Phase 4 Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline. Completed
  6. Phase 4 Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study Completed
Show 30 more trials
  1. Phase 4 Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib Completed
  2. Phase 4 CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib Completed
  3. Phase 4 Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response Completed
  4. Phase 3 Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib. Completed
  5. Phase 3 A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase Completed
  6. Phase 3 Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients Completed
  7. Phase 3 Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients Completed
  8. Phase 3 Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib Completed
  9. Phase 3 A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Completed
  10. Phase 3 Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib Completed
  11. Phase 2 Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis Completed
  12. Phase 2 Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Completed
  13. Phase 2 Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. Completed
  14. Phase 2 Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop) Completed
  15. Phase 2 Study of Platelet Derived Growth Factor Receptor (PDGFR) in Recurrent Malignant Gliomas Completed
  16. Phase 2 Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) Completed
  17. Phase 2 A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies Completed
  18. Phase 2 Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response. Completed
  19. Phase 2 Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma Completed
  20. Phase 2 Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment Completed
  21. Phase 2 A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation Completed
  22. Phase 2 Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML Completed
  23. Phase 2 Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor Completed
  24. Phase 2 A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation Completed
  25. Phase 2 Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib Completed
  26. Phase 2 Stem Cell Monitoring for CML Patients Undergoing Nilotinib Therapy Completed
  27. Phase 2 Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Completed
  28. Phase 1 Nilotinib in Preventing Paclitaxel-Induced Peripheral Neuropathy in Patients With Stage I-III Breast Cancer Completed
  29. Phase 1 A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL) Completed
  30. N/A Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database Completed

Showing the 36 most-cited and recently-updated of 36 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
6-month IS value predicts MR4.5 attainment and TKI discontinuation eligibility in CML patients
Hematology Phase III
6-month IS value predicts MR4.5 attainment and TKI discontinuation eligibility in CML patients Trial Shows Early Markers Predict Success in Chronic Myeloid Leukemia
This observational study of 431 patients with chronic myeloid leukemia (CML) on second-generation TKIs found that the 6-month IS value is a …
New data from a Phase 3 trial shows that early markers can help predict which patients with chronic myeloid leukemia may reach specific trea…
Aug 25, 2026
Combining pegylated interferon with nilotinib improves early molecular response in newly diagnosed chronic phase chronic myeloid leukaemia
Oncology RCT
Combining pegylated interferon with nilotinib improves early molecular response in newly diagnosed chronic phase chronic myeloid leukaemia Adding a weekly shot to a daily leukemia pill boosts deep remission rates
This phase 3 trial compared nilotinib monotherapy against nilotinib combined with pegylated interferon alfa-2a in patients with newly diagno…
A weekly injection added to a daily pill helped more newly diagnosed CML patients reach deep remission, but it also caused more side effects…
May 3, 2026
FDA Approves Danziten (nilotinib) for Adult Patients with Newly Diagnosed or Resistant/Intolerant Ph+ CML
Oncology FDA Approval
FDA Approves Danziten (nilotinib) for Adult Patients with Newly Diagnosed or Resistant/Intolerant Ph+ CML The FDA approved a new drug called Danziten for a type of blood cancer called CML
Danziten (nilotinib) is approved for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)…
The FDA approved Danziten to treat newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia or cases resistant to prior ima…
FDA Apr 17, 2026