Efficacy and Safety of TKIs' Withdrawal After a Two-step Dose Reduction in Patients with Chronic Myeloid Leukemia

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

June 16, 2020

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Chronic Myeloid Leukemia, Chronic PhaseWithdrawal;Drug
Interventions
DRUG

Imatinib withdrawal

withdrawal of imatinib after previous two-step dose reduction: during the first 6 months after study entry, the dose of imatinib is 50% of the standard dose (200 mg daily), during the second 6 months after study entry, the dose of imatinib is 200 mg every other day; 12 months after study entry, imatinib is discontinued, the patient is followed in line with the aims of the trial

DRUG

Dasatinib

withdrawal of dasatinib after previous two-step dose reduction: during the first 6 months after study entry, the dose of dasatinib is 50% of the standard dose (40 mg daily; tablets containing 50 mg are not available on the market), during the second 6 months after study entry, the dose of dasatinib is 40 mg every other day; 12 months after study entry, dasatinib is discontinued, the patient is followed in line with the aims of the trial

DRUG

Nilotinib

withdrawal of nilotinib after previous two-step dose reduction: during the first 6 months after study entry, the dose of nilotinib is 50% of the standard dose (200 mg every 12 hours), during the second 6 months after study entry, the dose of nilotinib is 400 mg every other day; 12 months after study entry, nilotinib is discontinued, the patient is followed in line with the aims of the trial

Trial Locations (8)

10034

University Hospital Kralovske Vinohrady, Prague

12800

Insitute of Hematology and Blood Transfusion, Prague

12808

General University Hospital in Prague, Prague

30599

University Hospital Plzen, Pilsen

50005

University Hospital Hradec Kralove, Hradec Králové

62500

University Hospital Brno, Brno

70852

University Hospital Ostrava, Ostrava

77900

University Hospital Olomouc, Olomouc

All Listed Sponsors
lead

Masaryk University

OTHER