A Phase 2 interventional study of Imatinib and Nilotinib in Chronic Myeloid Leukemia, Chronic Myeloid Leukemia in Remission and BCR-ABL Positive Chronic Myelogenous Leukemia, sponsored by National Research Center for Hematology, Russia. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by National Research Center for Hematology, Russia · Phase 2, Interventional, and Treatment
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.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 100 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →National Research Center for Hematology, Russia is the lead sponsor of 21 studies on the registry; 6 are open to participants now.
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For patients who are on the reduced dose TKI (1 stage) at the time of inclusion in the study
For patients on the reduced dose TKI (2 stage, before TFR phase) at the time of inclusion in the study
Exclusion Criteria:
Imatinib, nilotinib, dasatinib or bosutinib; the two stage of TKI dose reduction phase for 12 months (6 months and 6 months, respectively).
Drug: Imatinib · Drug: Nilotinib · Drug: Dasatinib · Drug: Bosutinib
Initial dose - 400 mg daily. If on imatinib, the dose should be decreased to 300 mg daily on the first stage, to 200 mg daily - on the second stage.
Initial dose - 300 or 400 mg twice daily. If on nilotinib to 400mg daily on the first stage, to 200 mg daily - on the second stage.
Initial dose 100 or 140 mg daily. If on dasatinib then to 50 mg daily on the first stage, to 25 mg daily - on the second stage.
Initial dose 500 mg daily. If on bosutinib, the dose should be reduced to 300 mg daily on the first stage, to 200 mg daily on the second stage.
Overall survival, survival without molecular relapse
Time frame: 37 months
The proportion of patients with molecular relapse who achieved MMR and DMR after the resumption TKI therapy in standard doses
Time frame: 37 months
The proportion of patients who resolved the adverse events after TKI dose reduction and discontinuation of TKI therapy
Time frame: 37 months
The proportion of patients who have TKI withdrawal syndrome after TKI dose reduction and discontinuation of TKI therapy.
Time frame: 37 months
Clinical factors, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
sex (male, female)
Time frame: 37 months
Clinical factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
age
Time frame: 37 months
Clinical factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
risk group (Sokal, ELTS) at the time of diagnosis
Time frame: 37 months
Clinical factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
duration of previous TKI treatment
Time frame: 37 months
Biological factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
Duration of molecular response
Time frame: 37 months
Biological factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.
Molecular response at the time of inclusion in the study
Time frame: 37 months
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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National Research Center for Hematology, Russia