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.


CML Clinical Trials Database

1. First line trials

1 KISS = Kinase Inhibition With Sprycel Start up [New Zealand]
Updated: 10 July 2018
2 SUSTRENIM = Sustained Treatment-free Remission in Chronic Myeloid Leukemia [Belgium, Italy, Netherlands]
Updated: 1 December 2017
3 DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]
Updated: 2 August 2018

2. Trials after therapy failure or intolerance

1 BOSTRO = CML Treated With Bosutinib After Relapse [Spain]
Updated: 13 February 2018
2 DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany] (2)
Updated: 2 August 2018
3 OPUS = Optimizing Ponatinib Use [Italy]
Updated: 18 December 2017
4 PF-114 Dose-finding Study in Ph+ CML Patients Resistant to 2nd Generation TKI or Presenting T315I Mutation [Russia]
Updated: 7 February 2018
5 CABL001X2101 = A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With CML or Ph+ ALL [Asia, Australia, Europe]
Updated: 29 March 2018
6 CABL001A2301 = ABL001 versus bosutinib in CML-CP patients pretreated with ≥2 TKI [Asia, Australia, Europe, North America, South America]
Updated: 28 March 2018
7 BEST - Bosutinib in Elderly Chronic Myeloid Leukemia [Italy]
Updated: 18 December 2017

3. Therapy optimization trials

1 DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany] (3)
Updated: 2 August 2018
2 ACTIW = Therapies in Combination or Sequentially with TKIs in CML-CP Patients in Complete Cytogenic Remission [France]
Updated: 29 March 2018
3 OPTIC = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]
Updated: 25 July 2017
4 Pioglitazone and TKI [USA]
Updated: 16 August 2017
5 Ruxolitinib for CML with minimal residual disease [USA]
Updated: 29 March 2018

4. Treatment of advanced phases

5. Treatment discontinuation trials

1 QMH-CML-001 = Cessation of TKI in CML [Hong Kong]
Updated: 27 April 2018
2 TRAD = Treatment-free Remission Accomplished With Dasatinib in Patients With CML [Canada]
Updated: 1 November 2017
3 DASTOP-2 (CA180-655) = Second treatment stop [Denmark, Finland, France, Germany, Sweden, Norway, The Netherlands]
Updated: 28 May 2018
4 NAUT (CAMN107ADE22T) = Efficacy of nilotinib in inducing persistence of molecular remission after second TKI stop [Europe]
Updated: 29 March 2018
5 MSIT = Malaysia Stop Tyrosine Kinase Inhibitor Trial [Malaysia]
Updated: 29 March 2018
6 ENESTPath Patient's Voice Italian Substudy [Italy]
Updated: 15 February 2016
7 PIO2STOP = Second STOP After Pioglitazone Priming in CML Patients [France]
Updated: 28 March 2018

6. Pediatric trials

1 BCHILD - Bosutinib in Pediatric Patients [France, Ireland, Italy, Netherlands, Spain, Switzerland]
Updated: 17 September 2018

7. Other trials

1 TOPASE - Therapeutic Observatory of Ponatinib About Safety and Efficacy [France]
Updated: 11 April 2018
2 CLR_15_03 = Safety, Tolerability and Pharmacokinetics of K0706 [Asia, Europe, USA]
Updated: 28 April 2018
3 Prospective Registry of Ponatinib in Belgium [Belgium]
Updated: 2 February 2018
4 OMNI = Registry to evaluate vascular occlusive events with Iclusig [US]
Updated: 2 August 2017
5 PONDEROSA [Germany]
Updated: 17 September 2018

9. Trials that are no longer recruiting

1 Matchpoint - Ponatinib and Intensive Chemotherapy [UK]
Updated: 17 September 2018
2 DASFREE (CA180-406) = Discontinuation of dasatinib in CP-CML patients with stable MR4.5
Updated: 21 June 2016
3 CAMN107A2203 = Study of the Efficacy and Safety of Oral Nilotinib in CML in Children and Adolescents
Updated: 31 January 2017
4 DASPERSE = Dasatinib in chronic phase myeloid leukemia patients with chronic toxicity to imatinib
Updated: 7 July 2015
5 ENESTFreedom = Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
Updated: 27 January 2017
6 CA180-357 = Decitabine + Dasatinib for Blast Phase CML
Updated: 7 February 2018
7 DECLINE (CAMN107ADE18T) = Imatinib versus nilotinib in CML in chronic phase [Germany]
Updated: 17 September 2018
8 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
Updated: 13 March 2015
9 TIGER (CML V) = Nilotinib or nilotinib + peginterferon with the aim to discontinue treatment
Updated: 30 August 2017
10 SIMPLICITY (CA180-330)
Updated: 7 July 2015
11 SPIRIT2 = Comparison of imatinib versus dasatinib in patients with newly-diagnosed chronic phase chronic myeloid leukaemia Scientific title
Updated: 22 January 2015
12 BFORE (AV001) = Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Updated: 25 September 2017
13 LAST Stopping Tyrosine kinase inhibitors
Updated: 1 November 2017
14 OPTIC 2L = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]
Updated: 19 November 2017
15 CML-Paed II = Registration of Children with CML and Treatment with Imatinib [Germany]
Updated: 6 November 2017
16 EUROSKI (EUROStopKinaseInhibitor)
Updated: 2 December 2014
17 CHOICES = Imatinib Mesylate With or Without Hydroxychloroquine in Treating Patients With Chronic Myeloid Leukemia
Updated: 14 April 2015
18 EUREKA = ELN registry
Updated: 8 November 2017
19 ENESTPath = A Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML
Updated: 6 July 2015
20 Eltrombopag for thrombocytopenia in CML
Updated: 1 November 2017

8. Other haematological trials (not CML)

1 DACOTA = Decitabine with or without Hydroxyurea versus Hydroxyurea in CMML[Europe]
Updated: 4 November 2015