HALF = Efficacy and safety of TKI withdrawal after a two-step dose reduction in patients with CML [Czechia]
Type of study
Treatment discontinuation trial
Phase
Current status
Active, not recruiting
Study title
HALF = Efficacy and safety of TKIs‘ withdrawal after a two-step dose reduction in patients with chronic myeloid leukemia (CML)
Scientific title
A prospective phase II clinical trial evaluating the efficacy and the safety of tyrosine kinase inhibitors withdrawal after a previous two-step dose reduction in patients with chronic myeloid leukemia in deep molecular remission
Other trial ID
HALF2019, ClinicalTrials.gov NCT04147533
What is the purpose of the study
What will happen during the study
The dose of the TKI will be reduced in two steps: during the first 6 months after study entry by 50% of standard dose; during the second 6 months this already reduced dose will be given every other day; the medication is discontinued then and the patients are followed every month in the first 6 months after withdrawal, every 1.5 month in the next 6 months, and every 3 months in the next 12 months.
Key inclusion criteria
This study includes male or female patients who:
- are aged 18 years or older
- have a documented diagnosis of Philadelphia chromosome-positive (Ph1) and/or BCR-ABL1-positive CML in a documented first chronic phase, as defined in the study protocol
- have a typical [e13a2 (b2a2) or e14a2 (b3a2)] or atypical quantifiable type of BCR-ABL1 transcript on an international scale (IS)
- have been treated with a tyrosine kinase inhibitor (TKI) either in the first line, or in the second or other lines for intolerance only
- have been receiving a TKI for more than 4 years
- have been in deep molecular response, defined as MR4.0 or better, for more than 2 years.
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- have had Ph1-positive and / or BCR-ABL1-positive CML in the second chronic phase, in the accelerated phase or blast crisis (AP/BC) at any time in the history of the disease
- have a type of BCR-ABL1 transcript that cannot be quantified on an international scale
- have been treated with a TKI in the second or later lines due to treatment failure according to ELN (European LeukemiaNet) criteria in 2006, 2009 or 2013
- have failed TKI treatment according to ELN criteria of 2006, 2009 or 2013
- previously underwent allogeneic hematopoietic stem cell transplantation
- previously participated in a TKI withdrawal study with a real withdrawal history
- previously discontinued TKI treatment outside the study for other reasons (eg intolerance or pregnancy) lasting more than 9 months and / or if a treatment response was lost during less than 12 months prior to screening.
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
Study sponsor
Masaryk University
Žerotínovo náměstí 617/9
601 77 Brno
Czech Republic
Scientific lead / contact
Daniela Zackova, MD, PhD
Dpt. of Internal Medicine Hematology and Oncology
University Hospital Brno
Jihlavska 20
625 00 Brno
Czech Republic
Tel.: +420 53223 3642
E-mail: zackova.daniela@fnbrno.cz
Principal investigator
Daniela Zackova, University Hospital Brno
Study centers / principal investigators
Czechia
University Hospital Brno
Brno, 62500
University Hospital Hradec Kralove
Hradec Králové, 50005
University Hospital Olomouc
Olomouc, 77900
University Hospital Ostrava
17. listopadu 1790/5
Ostrava, 70852
Principal Investigator: Lukas Stejskal, MD
University Hospital Plzen
Plzen, 30599
University Hospital Kralovske Vinohrady
Praha 10, 10034
Insitute of Hematology and Blood Transfusion
Praha 2, 12800
General University Hospital in Prague
Praha 2, 12808