HALF = Efficacy and safety of TKI withdrawal after a two-step dose reduction in patients with CML [Czechia]

What is the purpose of the study

This study will evaluate the safety and efficacy of stopping treatment with a TKI (imatinib, dasatinib or nilotinib) in patients with CML in deep molecular remission after after the dose has been 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.

What will happen during the study

Key inclusion criteria

This study includes male or female patients 18 years and older with Ph1-positive and/or BCR-ABL1-positive CML in chronic phase who have been receiving treatment with a tyrosine kinase inhibitor (TKI) for more than 4 years. Treatment of TKI may have been given either in the first line or in the second or other lines for intolerance only. Previous interferon-α treatment is allowed with any treatment effect (intolerance/failure).

Patients can be considered for inclusion if they have been in molecular remission (MR4.0) or better for at least 2 years.

Additional criteria may apply.

Key exclusion criteria

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Czechia

University Hospital Brno
Jihlavska 20
Brno, 62500
PI: Daniela Zackova, MD, PhD

University Hospital Hradec Kralove
Sokolská 581
Hradec Králové, 50005
PI: Petra Belohlavkova, MD, PhD

University Hospital Olomouc
I. P. Pavlova 185/6
Olomouc, 77900
PI: Prof. Edgar Faber, MD, PhD

University Hospital Ostrava
17. listopadu 1790/5
Ostrava, 70852
PI: Lukas Stejskal, MD

University Hospital Plzen
Edvarda Beneše 1128/13
Plzen, 30599
PI: Michal Karas, MD, PhD

University Hospital Kralovske Vinohrady
Šrobárova 1150/50
Praha 10, 10034
PI: Olga Cerna, MD

Insitute of Hematology and Blood Transfusion
U Nemocnice 2094/1
Praha 2, 12800
PI: Hana Klamova, MD, PhD

General University Hospital in Prague
U nemocnice 2
Praha 2, 12808
PI: Eduard Cmunt, MD, PhD