Chronic Myeloid Leukemia Clinical Trial
Official title:
Prospective Non-randomized Stratified Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib) in Adults With Ph+ Chronic Myeloid Leukemia With Stable Deep Molecular Response
The main goal of this study is to evaluate the stability of molecular response (major and deep molecular response( MMR and DMR)) in patients with chronic myeloid leukemia (CML) with stable DMR after two-stage dose reduction phase and discontinuation treatment TKI: imatinib, nilotinib, dasatinib and bosutinib.
The duration of the dose reduction phase will be 12 months. This phase will have two stage of
6 months, respectively.
The dose of imatinib, nilotinib, dasatinib or bosutinib will be reduced by 25-50% on the
first stage, and by another 25% on the second stage.
- The initial dose of imatinib will be 400 mg daily. The dose will be reduced by 300 mg
daily on the first stage, by 200 mg daily - on the second stage.
- The initial dose of nilotinib will be 300 or 400 mg twice daily. The dose will be
reduced by 400 mg daily on the first stage, by 200 mg daily - on the second stage.
- The initial dose of dasatinib will be 100 or 140 mg daily. The dose will be reduced by
50 mg daily on the first stage, by 25 mg daily - on the second stage.
- The initial dose of bosutinib will be 500 mg daily. The dose will be reduced by 300 mg
daily on the first stage, by 200 mg daily - on the second stage.
All patients with stable deep molecular response (at least 2 years) will be included in
treatment free remission phase (TFR-phase). The duration of TFR-phase will be 24 months.
The CML patients can enter the study already on reduced doses TKI, if they will meet the
inclusion criteria.
It is possible to include patients, who have already received therapy with reduced doses of
TKI. The duration of TKI therapy with reduced doses of 1 stage should be at least 6 months,
if TKI doses meet of stage 1. The duration of TKI therapy with reduced doses of 2 stage
should be for at least 6 months and the general duration of TKI therapy with reduced doses
should be for at least 12 months, if TKI doses meet of stage 2.
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