Chronic Myeloid Leukemia

Oncology
10
Pipeline Programs
9
Companies
50
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
2
4
0
1
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
6100%
+ 11 programs with unclassified modality

On Market (1)

Approved therapies currently available

Novartis
TASIGNAApproved
nilotinib
Novartis
oral2007

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Novartis
NovartisBASEL, Switzerland
8 programs
1
2
1
AsciminibPhase 2Small Molecule1 trial
STI571Phase 24 trials
TASIGNA(Nilotinib)Phase 1Small Molecule5 trials
AsciminibN/ASmall Molecule1 trial
AsciminibN/ASmall Molecule1 trial
+3 more programs
Active Trials
NCT05421091Completed550Est. Feb 2024
NCT06092879Active Not Recruiting201Est. Dec 2026
NCT05943522Recruiting100Est. Jul 2025
+12 more trials
Roche
RocheSTAVANGER NORWAY, Norway
1 program
1
Imatinib mesylate 400 mgPhase 3
M&
Merck & Co.RAHWAY, NJ
1 program
1
NilotinibPhase 2Small Molecule1 trial
Active Trials
NCT01866553Terminated20Est. May 2016
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
VenetoclaxPhase 21 trial
Active Trials
NCT05701215Active Not Recruiting10Est. Jan 2026
Teva
TevaIsrael - Petach Tikva
1 program
1
Omacetaxine mepesuccinatePhase 1/21 trial
Active Trials
NCT02078960Terminated10Est. Nov 2017
Fusion Pharmaceuticals Inc.
1 program
1
PF-114Phase 1/21 trial
Active Trials
NCT02885766UnknownEst. May 2020
CT
1 program
1
mesylate imatinib capsulePhase 11 trial
Active Trials
NCT01795716CompletedEst. Jun 2013
Bristol Myers Squibb
2 programs
Stem Cell and Mutational AssayN/A1 trial
Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world SettingN/A1 trial
Active Trials
NCT01215487Completed68Est. May 2020
NCT01244750Completed1,494Est. Jan 2020
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
Patient Reported Outcome MeasureN/A1 trial
Active Trials
NCT04595851Terminated6Est. Jul 2022

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
NovartisNilotinib
NovartisNilotinib
NovartisNilotinib
NovartisNilotinib
NovartisNilotinib
NovartisNilotinib
NovartisNilotinib
NovartisNilotinib
NovartisNilotinib
NovartisNilotinib
NovartisNilotinib
NovartisNilotinib
NovartisAsciminib
AbbVieVenetoclax
NovartisNilotinib

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 5,852 patients across 50 trials

Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.

Start: Feb 2016Est. completion: Mar 2021171 patients
Phase 4Completed

Trial Evaluating Nilotinib as Treatment for Newly Diagnosed CML Patients in Accelerated Phase.

Start: Feb 2014Est. completion: Jan 20170
Phase 4Withdrawn

Efficacy and Safety of Nilotinib in CML-CP

Start: May 2013Est. completion: Oct 2016110 patients
Phase 4Completed

Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study

Start: Mar 2013Est. completion: Jul 202357 patients
Phase 4Completed

Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase

Start: May 2010Est. completion: Jul 20141,090 patients
Phase 4Completed

Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response

Start: Dec 2009Est. completion: Jan 201445 patients
Phase 4Completed

Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib

Start: Aug 2008Est. completion: Dec 202434 patients
Phase 4Completed

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)

Start: Nov 2022Est. completion: Jul 2031568 patients
Phase 3Active Not Recruiting

Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients

Start: Aug 2014Est. completion: Oct 2022200 patients
Phase 3Completed

Study to Assess Efficacy and Safety of Nilotinib 300mg Twice Daily in Patients With Philadelphia Positive Chronic Myeloid Leukaemia (CML) in Chronic Phase Who Are Intolerant to Prior Tyrosine Kinase Inhibitors.

Start: Jul 2014Est. completion: Aug 201620 patients
Phase 3Terminated

A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.

Start: Apr 2013Est. completion: Jul 2020620 patients
Phase 3Completed

Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

Start: Apr 2011Est. completion: Nov 2014421 patients
Phase 3Completed

Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

Start: Jan 2024Est. completion: Jul 203550 patients
Phase 2Recruiting

Venetoclax After TKI to Target Persisting Stem Cells in CML

Start: Aug 2023Est. completion: Jan 202610 patients
Phase 2Active Not Recruiting

A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia

Start: Mar 2019Est. completion: Oct 2025124 patients
Phase 2Completed

Stem Cell Monitoring for CML Patients Undergoing Nilotinib Therapy

Start: Jan 2015Est. completion: Feb 202116 patients
Phase 2Completed

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

Start: Aug 2013Est. completion: Aug 202059 patients
Phase 2Completed

Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment

Start: Jun 2013Est. completion: Oct 202315 patients
Phase 2Completed

Nilotinib Plus Pegylated Interferon-α2b in CML

Start: Apr 2013Est. completion: May 201620 patients
Phase 2Terminated

Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients

Start: Mar 2013Est. completion: Jan 2025215 patients
Phase 2Completed

Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)

Start: Dec 2012Est. completion: Jan 2025163 patients
Phase 2Completed

Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Start: Jan 2011Est. completion: Aug 2019112 patients
Phase 2Completed

Tasigna Neoadjuvant Gastrointestinal Stromal Tumor (GIST)

Start: Jan 20110
Phase 2Withdrawn

A Study of Nilotinib in Growing Vestibular Schwannomas

Start: Oct 2010Est. completion: Oct 20132 patients
Phase 2Terminated

Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor

Start: Sep 2010Est. completion: Aug 201517 patients
Phase 2Completed

Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)

Start: Jul 2010Est. completion: Jan 201323 patients
Phase 2Terminated

Study of Platelet Derived Growth Factor Receptor (PDGFR) in Recurrent Malignant Gliomas

Start: Apr 2010Est. completion: Jan 201938 patients
Phase 2Completed

Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma

Start: Jan 2009Est. completion: Mar 201420 patients
Phase 2Completed

Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Start: Sep 2008Est. completion: Sep 20112 patients
Phase 2Completed

Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML)

Start: Jun 2005Est. completion: Jul 2018148 patients
Phase 2Completed

Glivec in Prostate Cancer Patients With Rising PSA Following Radical Prostectomy

Start: Jun 200351 patients
Phase 2Completed

Study of the Combination of a Tyrosine Kinase Inhibitor (STI571) and a Pegylated Human Recombinant Interferon alfa2b (PEGINTRON)

Start: Apr 20015 patients
Phase 2Terminated

Protein-Tyrosine Kinase Inhibitor (STI571) for Treatment of Patients With Ph+ Chronic Myeloid Leukemia

Start: Aug 2000200 patients
Phase 2Completed

An Extension Study to Determine the Efficacy and Safety of STI571 in Participants With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha

Start: Dec 1999Est. completion: Nov 2013532 patients
Phase 2Completed

Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 for Oral Administration in Adults With Ph+ Chronic Myeloid Leukemia, Which is Resistant to the 2-nd Generation Bcr-Abl Inhibitors or Has T315I Mutation in the BCR-ABL Gene

Start: Jul 2016Est. completion: May 2020
Phase 1/2Unknown
NCT02078960TevaOmacetaxine mepesuccinate

A Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase (CP) or Accelerated Phase (AP) Chronic Myeloid Leukemia (CML) (Referred to as the SYNSINCT Study)

Start: Oct 2014Est. completion: Nov 201710 patients
Phase 1/2Terminated

Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia

Start: Aug 2013Est. completion: Dec 20184 patients
Phase 1/2Completed

Safety and Efficacy Study of Nilotinib Combined With Mitoxantrone, Etoposide, and High-dose Cytarabine Induction Chemotherapy Followed by Consolidation for Patients With C-kit Positive Acute Myeloid Leukemia

Start: Oct 2010Est. completion: Apr 201512 patients
Phase 1/2Terminated

A Phase l/ll Study of AMN107 in Adult Patients With Glivec-intolerant CML or Relapsed-refractory Ph+ALL

Start: May 200542 patients
Phase 1/2Completed

A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies

Start: Apr 2005Est. completion: Sep 2012507 patients
Phase 1/2Completed

Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

Start: Jun 2022Est. completion: Jun 203030 patients
Phase 1Recruiting

Predictive Biomarkers of Biological Activity and Efficacy of Nilotinib on ZAK Target in Non-metastatic Colon Cancer

Start: May 2016Est. completion: Nov 20170
Phase 1Withdrawn

Safety and Tolerability of Combined Treatment With Nilotinib and Ruxolitinib in CML and Ph+ ALL Patients

Start: Feb 2015Est. completion: Apr 20185 patients
Phase 1Completed

A Phase I Study of Nilontinib and Cetuximab in Patients With Solid Tumors

Start: May 2014Est. completion: Dec 201615 patients
Phase 1Terminated

Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body

Start: Sep 2012Est. completion: Jun 2013
Phase 1Completed

Determining the Maximum Tolerated Dose of Low Dose Interferon-alpha in Conjunction With Nilotinib in Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP)

Start: Apr 2012Est. completion: Jan 20144 patients
Phase 1Completed

Nilotinib and LDE225 in the Treatment of Chronic or Accelerated Phase Myeloid Leukemia in Patients Who Developed Resistance to Prior Therapy

Start: Jan 2012Est. completion: Feb 201411 patients
Phase 1Completed

A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)

Start: Apr 2011Est. completion: Jul 201515 patients
Phase 1Completed

Study of Tasigna®/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas

Start: Jan 2011Est. completion: Oct 20166 patients
Phase 1Completed

Phase 1 Nilotinib in Steroid Dependent/Refractory Chronic Graft Versus Host Disease

Start: Aug 2010Est. completion: Dec 201333 patients
Phase 1Completed

Related Jobs in Oncology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 5,852 patients
9 companies competing in this space