CML Clinical Trials

Cancer research is an area where new treatments are being explored for the prevention, diagnosis and treatment of different types of cancer. Researchers conduct so called "clinical studies" or "clinical trials" to improve treatment options for the patients of today and tomorrow. These studies are performed to investigate the biological mechanisms of the disease, to optimize the use of existing therapies or to test new forms of treatment or new drugs to find out whether they are more effective or better tolerated. For more information please read our manual "what are clinical trials?"

Patients wishing to participate in clinical studies often look for a central source of information where they can find easy-to-understand facts on ongoing trials. CML Advocates Network is now hosting an inofficial database of current CML trials which have been initiated by academia (universities) or by pharmaceutical companies. This database is run by patients for patients and is set up as a dynamic register in which data are updated on an ongoing basis. CML Advocates Network has taken utmost care to verify the data entered, however, cannot assume any liability for the accuracy or completeness of the information. Patients should consult their doctor for personal advice and/or their scientific contact/study staff for the most up-to-date study information.

Do you know of any study that is not yet listed here? Please let us know by filling out this form. Or is there an entry which should be corrected? If so, please send us an email. Please also visit our forum if you have any questions or wish to share your experience on these studies.


1. First line trials TOP LINK

# Article Title
1 KISS = Kinase Inhibition With Sprycel Start up [New Zealand]
2 SUSTRENIM = Sustained Treatment-free Remission in Chronic Myeloid Leukemia [Belgium, Italy, Netherlands]
3 DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]

2. Trials after therapy failure or intolerance TOP LINK

# Article Title
1 PONS = Ponatinib in second line [Germany]
2 BOSTRO = CML Treated With Bosutinib After Relapse [Spain]
3 DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]
4 OPUS = Optimizing Ponatinib Use [Italy]
5 PF-114 Dose-finding Study in Ph+ CML Patients Resistant to 2nd Generation TKI or Presenting T315I Mutation [Russia]
6 CABL001X2101 = A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With CML or Ph+ ALL [Asia, Australia, Europe]
7 CABL001A2301 = ABL001 versus bosutinib in CML-CP patients pretreated with ≥2 TKI [Asia, Australia, Europe, North America, South America]
8 BEST - Bosutinib in Elderly Chronic Myeloid Leukemia [Italy]

3. Therapy optimization trials TOP LINK

# Article Title
1 S1712 = Ruxolitinib Phosphate and Dasatinib or Nilotinib in Treating Patients With Chronic Myeloid Leukemia [USA]
2 OPTIC = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]
3 ASC4MORE (CABL001E2201) = A Phase II Study of ABL001 in Patients With CP CML without Deep Molecular Response [Asia, Australia, Europe, USA]
4 DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]
5 ACTIW = Therapies in Combination or Sequentially with TKIs in CML-CP Patients in Complete Cytogenic Remission [France]
6 OPTIC = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]
7 Pioglitazone and TKI [USA]
8 Ruxolitinib for CML with minimal residual disease [USA]

5. Treatment discontinuation trials TOP LINK

# Article Title
1 QMH-CML-001 = Cessation of TKI in CML [Hong Kong]
2 DASTOP-2 (CA180-655) = Second treatment stop [Denmark, Finland, France, Germany, Sweden, Norway, The Netherlands]
3 NAUT (CAMN107ADE22T) = Efficacy of nilotinib in inducing persistence of molecular remission after second TKI stop [Europe]
4 MSIT = Malaysia Stop Tyrosine Kinase Inhibitor Trial [Malaysia]
5 ENESTPath Patient's Voice Italian Substudy [Italy]
6 PIO2STOP = Second STOP After Pioglitazone Priming in CML Patients [France]

6. Pediatric trials TOP LINK

# Article Title
1 BCHILD - Bosutinib in Pediatric Patients [France, Ireland, Italy, Netherlands, Spain, Switzerland]

7. Other trials TOP LINK

# Article Title
1 Observational Study of Iclusig® (Ponatinib) Treatment in Patients with Chronic Myeloid Leukaemia (CML) [Italy]
2 TOPASE - Therapeutic Observatory of Ponatinib About Safety and Efficacy [France]
3 CLR_15_03 = Safety, Tolerability and Pharmacokinetics of K0706 [Asia, Europe, USA]
4 Prospective Registry of Ponatinib in Belgium [Belgium]
5 OMNI = Registry to evaluate vascular occlusive events with Iclusig [US]
6 PONDEROSA [Germany]

9. Trials that are no longer recruiting TOP LINK

# Article Title
1 Matchpoint - Ponatinib and Intensive Chemotherapy [UK]
2 DASFREE (CA180-406) = Discontinuation of dasatinib in CP-CML patients with stable MR4.5
3 TRAD = Treatment-free Remission Accomplished With Dasatinib in Patients With CML [Canada]
4 CAMN107A2203 = Study of the Efficacy and Safety of Oral Nilotinib in CML in Children and Adolescents
5 DASPERSE = Dasatinib in chronic phase myeloid leukemia patients with chronic toxicity to imatinib
6 ENESTFreedom = Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
7 DECLINE (CAMN107ADE18T) = Imatinib versus nilotinib in CML in chronic phase [Germany]
8 CA180-357 = Decitabine + Dasatinib for Blast Phase CML
9 ENESTop = A clinical research study evaluating the possibility to stop the drug nilotinib in chronic myeloid leukemia (CML) patients who have very small amount of leukemia cells remaining after nilotinib treatment
10 TIGER (CML V) = Nilotinib or nilotinib + peginterferon with the aim to discontinue treatment
11 SIMPLICITY (CA180-330)
12 SPIRIT2 = Comparison of imatinib versus dasatinib in patients with newly-diagnosed chronic phase chronic myeloid leukaemia Scientific title
13 BFORE (AV001) = Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
14 LAST Stopping Tyrosine kinase inhibitors
15 OPTIC 2L = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]
16 CML-Paed II = Registration of Children with CML and Treatment with Imatinib [Germany]
17 EUROSKI (EUROStopKinaseInhibitor)
18 CHOICES = Imatinib Mesylate With or Without Hydroxychloroquine in Treating Patients With Chronic Myeloid Leukemia
19 EUREKA = ELN registry
20 ENESTPath = A Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML

8. Other haematological trials (not CML) TOP LINK

# Article Title
1 DACOTA = Decitabine with or without Hydroxyurea versus Hydroxyurea in CMML[Europe]