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AITIK-Discontinuation of TyrosIne Kinase Inhibitors (TKI) in Chronic Myeloid Leukemia (CML) and Impact on the Immune System
EU CTIS ID: 2024-515479-36-00
What this study is testing
To compare 2 TKI discontinuation strategies on the probability of successful discontinuation in patients followed for CML treated with TKIs.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient aged ≥ 18 years
- Diagnosed with chronic phase CML (CML-CP) according to WHO 2016 criteria with a typical BCR::ABL1 rearrangement (e13a2/b2a2 or e14a2/b3a2)
- Duration Imatinib ≥ 4 years/ TKI2G ≥ 3 years / Imatinib + ITK2G ≥ 4 years and not having had a dose reduction in the last 6 months
- Duration of DMR (≥ 4-log reduction in peripheral blood BCR::ABL1 mRNA level from diagnosis) ≥ 1 year
- No contraindication to the continuation of the same TKI for 12 months at the same dosage according to international recommendations and the originator's CPR of each TKI i.e.: Glivec® or generic: Imatinib (≥ 300 mg/d) Sprycel® or generic: Dasatinib (≥ 50 mg/d) Tasigna®: Nilotinib (≥ 300 mg/d) Bosulif®: Bosutinib (≥ 200 mg/d)
- Sexually active men should use contraception while taking Dasatinib
You likely can't join if
- Patients with a serious progressive disease with poor prognosis compromising participation in the entire study and/or with an uncontrolled chronic disease (cardiac, (recent myocardial infarction, congestive heart failure, unstable angina...), renal, respiratory...)
- ECOG > 3
- Previous resistance to a TKI
- Patients who have already involving a TKI discontinuation strategy
- Patients with a malignant tumour that has been treated with chemotherapy in the 2 months prior to inclusion or is currently undergoing chemotherapy or will be treated with chemotherapy after inclusion
- Persons benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection and finally patients in emergency situations
See the full eligibility criteria
- Patient aged ≥ 18 years
- Diagnosed with chronic phase CML (CML-CP) according to WHO 2016 criteria with a typical BCR::ABL1 rearrangement (e13a2/b2a2 or e14a2/b3a2)
- Duration Imatinib ≥ 4 years/ TKI2G ≥ 3 years / Imatinib + ITK2G ≥ 4 years and not having had a dose reduction in the last 6 months
- Duration of DMR (≥ 4-log reduction in peripheral blood BCR::ABL1 mRNA level from diagnosis) ≥ 1 year
- No contraindication to the continuation of the same TKI for 12 months at the same dosage according to international recommendations and the originator's CPR of each TKI i.e.: Glivec® or generic: Imatinib (≥ 300 mg/d) Sprycel® or generic: Dasatinib (≥ 50 mg/d) Tasigna®: Nilotinib (≥ 300 mg/d) Bosulif®: Bosutinib (≥ 200 mg/d)
- Sexually active men should use contraception while taking Dasatinib
- Must be affiliated to the social security system or have a third party who does so
- Patient not participating in another interventional study for the duration of the study
- Have signed the consent form after having read the information note
- Patients with a serious progressive disease with poor prognosis compromising participation in the entire study and/or with an uncontrolled chronic disease (cardiac, (recent myocardial infarction, congestive heart failure, unstable angina...), renal, respiratory...)
- ECOG > 3
- Previous resistance to a TKI
- Patients who have already involving a TKI discontinuation strategy
- Patients with a malignant tumour that has been treated with chemotherapy in the 2 months prior to inclusion or is currently undergoing chemotherapy or will be treated with chemotherapy after inclusion
- Persons benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection and finally patients in emergency situations
- Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)
- Patients who lost their DMR at the inclusion visit (i.e. BCR::ABL1/ABL1 ratio > 0.01%)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.