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
- Asciminib in Patients With Newly Diagnosed CML in Chronic Phase [USA]
- ALERTCML (CABL001AUS06T) = Asciminib as initial therapy for patients with CML in chronic phase [USA]
- ASC4START (CABL001J12302) = Asciminib versus nilotinib in patients with newly diagnosed CML [Asia-Pacific, Africa, Europe, Middle East, North America, South America]
- Nilotinib20190426 = Nilotinib for First-line Newly Diagnosed CML-CP [China]
2. Trials after therapy failure or intolerance
- CARDINAL (TERN-701) = TERN-701 in Chronic Myeloid Leukemia [USA]
- OLV20220331 = Olverembatinib in Chronic Phase CML [China]
- ASC2ESCALATE (CABL001AUS08) = Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia [USA]
- ELVN-001 for the Treatment of Chronic Myeloid Leukemia [Australia, France, Germany, Republic of Korea, Spain, USA]
- RT51KRI03 = Radotinib in Chronic Phase Chronic Myeloid Leukemia [Republic of Korea, Russia, Turkey, Ukraine]
- HQP1351CU101 = Study of HQP1351 in subjects with refractory chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia [USA]
3. Therapy optimization trials
- VARIANT = Venetoclax After TKI to Target Persisting Stem Cells in CML [Germany]
- HE22-00031 = Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia [Mexico]
- CABL001A2001B = Asciminib Roll-over Study [Asia-Pacific, Europe, Middle East, Central America, North America, South America]
- PONTrack = With ponatinib on the track for treatment-free remission in CML [Germany]
4. Treatment of advanced phases
5. Treatment discontinuation trials
- AITIK = Discontinuation of Tyrosine Kinase Inhibitor in CML and Impact on the Immune System [France]
- QC-TFR1-ABL001 = Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML [Canada]
- AAML18P1 = Stopping TKI in Affecting Treatment-Free Remission in CP CML [Australia, Canada, Puerto Rico, USA]
- DANTE = De-escalation and TFR Study in CML Patients Treated With Nilotinib Followed by a Second Attempt After Nilotinib and Asciminib Combination [Italy]
- TOKIN = TKI cessation for CML patients with stable molecular response in a real world population [USA]
6. Pediatric trials
- INCB84344-102 = Ponatinib for Treatment of Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors in children [Europe]
- AAML18P1 = Stopping TKI in Affecting Treatment-Free Remission in CP CML [Australia, Canada, Puerto Rico, USA]
- ASC4KIDS = Asciminib in Pediatric Patients with CML [China, Europe, Japan, Republic of Korea, Russian Federation, Thailand, Turkey]
7. Other trials
9. Trials that are no longer recruiting
- LEONIDAS = Quality-of-Life effects of imatinib and dasatinib in CML
- CA180-373 = A Phase 1B Study with Dasatinib plus Nivolumab in CML
- BYOND (B1871039) = Safety and Efficacy of Bosutinib in Ph+ CML Previously Treated with TKI
- DASCERN (CA180-399) = Phase IIb Study of Dasatinib versus Imatinib (Early Switch)
- Eltrombopag for thrombocytopenia in CML
- ENESTPath = A Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML
- EUREKA = ELN registry
- CHOICES = Imatinib Mesylate With or Without Hydroxychloroquine in Treating Patients With Chronic Myeloid Leukemia
- EUROSKI (EUROStopKinaseInhibitor)
- CML-Paed II = Registration of Children with CML and Treatment with Imatinib [Germany]
- OPTIC 2L = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]
- LAST Stopping Tyrosine kinase inhibitors
- BFORE (AV001) = Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
- SPIRIT2 = Comparison of imatinib versus dasatinib in patients with newly-diagnosed chronic phase chronic myeloid leukaemia Scientific title
- SIMPLICITY (CA180-330)
- Ruxolitinib for CML with minimal residual disease [USA]
- TIGER (CML V) = Nilotinib or nilotinib + peginterferon with the aim to discontinue treatment
- Pioglitazone and TKI [USA]
- OPTIC = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]
- 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
- PF-114 Dose-finding Study in Ph+ CML Patients Resistant to 2nd Generation TKI or Presenting T315I Mutation [Russia]
- CA180-357 = Decitabine + Dasatinib for Blast Phase CML
- DECLINE (CAMN107ADE18T) = Imatinib versus nilotinib in CML in chronic phase [Germany]
- MSIT = Malaysia Stop Tyrosine Kinase Inhibitor Trial [Malaysia]
- PIO2STOP = Second STOP After Pioglitazone Priming in CML Patients [France]
- BEST – Bosutinib in Elderly Chronic Myeloid Leukemia [Italy]
- ENESTFreedom = Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
- DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]
- NAUT (CAMN107ADE22T) = Efficacy of nilotinib in inducing persistence of molecular remission after second or third TKI stop [Europe]
- DASPERSE = Dasatinib in chronic phase myeloid leukemia patients with chronic toxicity to imatinib
- SUSTRENIM = Sustained Treatment-free Remission in Chronic Myeloid Leukemia [Belgium, Italy, Netherlands]
- DASTOP-2 (CA180-655) = Second treatment stop [Denmark, Finland, France, Germany, Sweden, Norway, The Netherlands]
- ASCEMBL (CABL001A2301) = ABL001 versus bosutinib in CML-CP patients pretreated with ≥2 TKI [Asia, Australia, Europe, North America, Central America, South America]
- BOSTRO = CML Treated With Bosutinib After Relapse [Spain]
- CABL001X2101 = A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With CML or Ph+ ALL [Asia, Australia, Europe]
- OMNI = Registry to evaluate vascular occlusive events with Iclusig [USA]
- QMH-CML-001 = Cessation of TKI in CML [Hong Kong]
- PONDEROSA [Czechia, Germany]
- OPUS = Optimizing Ponatinib Use [Italy]
- CA180-226 = Dasatinib Powder for Oral Suspension Substudy [Mexico, Romania, Spain, USA]
- ENESTPath Patient’s Voice Italian Substudy [Italy]
- DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]
- Low Dose Dasatinib as First-Line Treatment [Middle East]
- DIALOG (CAMN107A2203) = Study of the Efficacy and Safety of Oral Nilotinib in CML in Children and Adolescents
- DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]
- Prospective Registry of Ponatinib in Belgium [Belgium]
- ENDURE = Efficacy and Safety of AOP2014 With CML Patients in Remission [France, Germany]
- ASC4MORE (CABL001E2201) = A Phase II Study of ABL001 in Patients With CML-CP without Deep Molecular Response [Asia, Australia, Europe, North America, South America]
- TRAD = Treatment-free Remission Accomplished With Dasatinib in Patients With CML [Canada]
- RERISE China = Radotinib versus Imatinib [China]
- DASFREE (CA180-406) = Discontinuation of dasatinib in CP-CML patients with stable MR4.5
- CALLS = CML and ALL Low Level Mutation Study in the UK [UK]
- OPTIC = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]
- Matchpoint – Ponatinib and Intensive Chemotherapy [UK]
- FAsciNation = Frontline Asciminib Combination in Chronic Phase CML (CML XI) [Germany]
- DACOTA = Decitabine with or without Hydroxyurea versus Hydroxyurea in CMML[Europe]
- TOPASE = Therapeutic Observatory of Ponatinib About Safety and Efficacy [France]
- BCHILD = Bosutinib in Pediatric Patients [Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, Switzerland, UK, USA]
- PonaZero = Effect of Consolidation Treatment with Ponatinib on TFR Rate [Spain]
- ResToP = Reinduction and Second Stop of TKI With Ponatinib in CML [Spain]
- HALF = Efficacy and safety of TKI withdrawal after a two-step dose reduction in patients with CML [Czechia]
- PONAZA = Ponatinib and subcutaneous azacitidine in chronic myelogenous leukemia patients in accelerated phase or in myeloid blast crisis [France]
- ACTIW = Therapies in Combination or Sequentially with TKIs in CML-CP Patients in Complete Cytogenic Remission [France]
- S1712 = Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for CML [USA]
- AIM4CML = Asciminib monotherapy for patients with CML-CP with and without T315I mutation [USA]
- ASC4OPT = Asciminib treatment optimization in ≥ 3rd line CML-CP [Argentina, Canada, Europe, Republic of Korea, Malaysia, Russian Federation, Singapore]
- PONS = Ponatinib in Second Line [Germany]
- CLR_15_03 = Safety and anti-leukemic activity of vodobatinib (K0706) for resistant/intolerant CML [Asia, Europe, USA]
- CarPAs = Cardiovascular assessment of ponatinib as third line treatment in CML [Italy]
- KISS = Kinase Inhibition With Sprycel Start up [New Zealand]
- TIPI = Ponatinib followed by Imatinib in Chronic Phase Chronic Myeloid Leukemia [France]
- ASC4FIRST = Oral Asciminib Versus Other TKIs in Newly Diagnosed Ph+ CML-CP [Asia-Pacific, Australia, Europe, Israel, North America, Russian Federation]