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

1 FAsciNation = Frontline Asciminib Combination in Chronic Phase CML (CML XI) [Germany]
2 ASC4FIRST (CABL001J12301) = Oral Asciminib Versus Other TKIs in Newly Diagnosed Ph+ CML-CP [Asia-Pacific, Australia, Europe, North America]
3 Nilotinib20190426 = Nilotinib for First-line Newly Diagnosed CML-CP [China]
4 TIPI = Ponatinib followed by Imatinib in Chronic Phase Chronic Myeloid Leukemia [France]
5 KISS = Kinase Inhibition With Sprycel Start up [New Zealand]

2. Trials after therapy failure or intolerance TOP LINK

1 CarPAs = Cardiovascular assessment of ponatinib as third line treatment in CML [Italy]
2 HQP1351CU101 = Study of HQP1351 in subjects with refractory chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia [USA]
3 RT51KRI03 = Radotinib in Chronic Phase Chronic Myeloid Leukemia [Republic of Korea, Russia, Turkey, Ukraine]
4 CLR_15_03 = Safety and anti-leukemic activity of vodobatinib (K0706) for refractory/intolerant CML [Asia, Europe, USA]
5 PONS = Ponatinib in Second Line [Germany]

3. Therapy optimization trials TOP LINK

1 ASC4OPT (CABL001A2302) = Asciminib treatment optimization in ≥ 3rd line CML-CP [Europe, Republic of Korea, Malaysia, Russian Federation]
2 PONTrack = With ponatinib on the track for treatment-free remission in CML [Germany]
3 AIM4CML (CABL001AUS04) = Asciminib monotherapy for patients with CML-CP with and without T315I mutation [USA]
4 S1712 = Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for CML [USA]
5 ACTIW = Therapies in Combination or Sequentially with TKIs in CML-CP Patients in Complete Cytogenic Remission [France]

4. Treatment of advanced phases TOP LINK

1 PONAZA - Ponatinib and subcutaneous azacitidine in chronic myelogenous leukemia patients in accelerated phase or in myeloid blast crisis [France]

5. Treatment discontinuation trials TOP LINK

1 TOKIN = TKI cessation for CML patients with stable molecular response in a real world population [USA]
2 HALF = Efficacy and safety of TKI withdrawal after a two-step dose reduction in patients with CML [Czechia]
3 ResToP = Reinduction and Second Stop of TKI With Ponatinib in CML [Spain]
4 DANTE = A study of full treatment-free remission in patients with CML treated with nilotinib [Italy]
5 PonaZero = Effect of Consolidation Treatment with Ponatinib on TFR Rate [Spain]

6. Pediatric trials TOP LINK

1 CABL001I12201 = Asciminib in Pediatric Patients with CML [Europe, Russian Federation, Thailand, Turkey]
2 AAML18P1 = Stopping TKI in Affecting Treatment-Free Remission in CP CML [Australia, Canada, Puerto Rico, United States]
3 BCHILD - Bosutinib in Pediatric Patients [Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, Switzerland, UK, USA]

7. Other trials TOP LINK

1 BlastCrisis = European CML Blast Crisis Register [Czechia, Germany, Russian Federation, Ukraine]
2 TOPASE - Therapeutic Observatory of Ponatinib About Safety and Efficacy [France]
3 PONDEROSA [Czechia, Germany]

9. Trials that are no longer recruiting TOP LINK

1 DACOTA = Decitabine with or without Hydroxyurea versus Hydroxyurea in CMML[Europe]
2 OPTIC = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]
3 INCB84344-102 = Safety and efficacy of ponatinib for recurrent or refractory leukemias or solid tumors in children [Europe]
4 Matchpoint - Ponatinib and Intensive Chemotherapy [UK]
5 CALLS = CML and ALL Low Level Mutation Study in the UK [UK]
6 DASFREE (CA180-406) = Discontinuation of dasatinib in CP-CML patients with stable MR4.5
7 RERISE China = Radotinib versus Imatinib [China]
8 TRAD = Treatment-free Remission Accomplished With Dasatinib in Patients With CML [Canada]
9 ASC4MORE (CABL001E2201) = A Phase II Study of ABL001 in Patients With CML-CP without Deep Molecular Response [Asia, Australia, Europe, North America, South America]
10 ENDURE = Efficacy and Safety of AOP2014 With CML Patients in Remission [France, Germany]
11 DIALOG (CAMN107A2203) = Study of the Efficacy and Safety of Oral Nilotinib in CML in Children and Adolescents
12 Prospective Registry of Ponatinib in Belgium [Belgium]
13 DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]
14 Low Dose Dasatinib as First-Line Treatment [Middle East]
15 DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]
16 CA180-226 = Dasatinib Powder for Oral Suspension Substudy [Mexico, Romania, Spain, USA]
17 ENESTPath Patient's Voice Italian Substudy [Italy]
18 OPUS = Optimizing Ponatinib Use [Italy]
19 QMH-CML-001 = Cessation of TKI in CML [Hong Kong]
20 CABL001X2101 = A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With CML or Ph+ ALL [Asia, Australia, Europe]

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