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Efficacy and Safety of TKIs' Withdrawal After a Two-step Dose Reduction in Patients with Chronic Myeloid Leukemia
Bu çalışma, kronik miyeloid lösemi (chronic myeloid leukemia) hastalarında iki aşamalı doz azaltımının ardından tirozin kinaz inhibitörü (TKİ) tedavisinin (Imatinib, Dasatinib, Nilotinib) tamamen kesilmesinin etkinliğini ve güvenliğini değerlendirmektedir. Çalışmaya, BCR-ABL1 pozitif, 4 yıldan uzun süre TKİ almış ve en az 2 yıldır derin moleküler yanıt (MR4.0 veya daha iyi) gösteren 18 yaş ve üzeri hastalar katılabilmektedir. Faz 2 aşamasında yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: 1. Patients with documented Ph1-positive and / or BCR-ABL1-positive CML in a documented first chronic phase, the criteria of which are as follows: * \<15% blasts in peripheral blood (PB) or bone marrow (BM) * \<30% blasts + promyelocytes in PB or BM * \<20% of basophils in PB * \>= 100 billion / l platelets * Absence of extramedullary involvement except hepato- and / or splenomegaly 2. Age \>= 18 years 3. Signed informed consent to study participation 4. Typical \[e13a2 (b2a2) or e14a2 (b3a2)\] or atypical quantifiable type of BCR-ABL1 transcript on an international scale 5. Treatment of TKI either in the first line or in the second or other lines for intolerance only 6. TKI treatment\> 4 years 7. Previous interferon-α treatment allowed with any treatment effect (intolerance / failure) 8. Deep molecular response \>= MR4.0 lasting \> 2 years 9. Participants in a fertile clinical trial must agree to use prescribed contraceptive methods from entry to study until one year after the last dose of study medication: * Women - Proper use of a highly reliable contraceptive method, ie combined hormonal contraceptives (in oral, vaginal or transdermal dosage form), gestagen hormonal contraceptives associated with ovulation inhibition (in oral or injectable dosage form), non-hormonal IUDs (intrauterine device) or IUDs , ev. presence of bilateral tubular occlusion, partner vasectomy, or adherence to sexual abstinence * Men - Observance of sexual abstinence or use of adequate contraceptive method (ie condom) in the case of sexual intercourse for the period from enrollment to 1 year after the last dose of the drug Exclusion Criteria: 1. Patients with 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 2. Non-quantifiable type of BCR-ABL1 transcript on an international scale 3. Treatment of TKI in the second or subsequent lines due to treatment failure according to ELN (European LeukemiaNet) criteria in 2006, 2009 or 2013 4. Previous failure of TKI treatment according to ELN criteria of 2006, 2009 or 2013 5. Previous allogeneic hematopoietic stem cell transplantation 6. Previous participation in a TKI withdrawal study with a real withdrawal history 7. Previous discontinuation of TKI 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 8. Life expectancy of less than 36 months due to severe concurrent disease 9. Severe concurrent disease that could limit adherence to study protocol or study completion 10. Pregnancy and breastfeeding 11. Disagreement or impossibility to comply with the contraceptive measures described in point 9 of the inclusion criteria