Status:
RECRUITING
Discontinuation of TyrosIne Kinase Inhibitors (TKI) in Chronic Myeloid Leukemia (CML) and Impact on the Immune System
Lead Sponsor:
Poitiers University Hospital
Conditions:
Tyrosine Kinase Inhibitors
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Tyrosine kinase inhibitors (TKI) have revolutionized the management and prognosis of chronic myeloid leukemia (CML). Daily treatment with TKI, which is necessary due to lack of cure, is frequently ass...
Eligibility Criteria
Inclusion Criteria:
- Patient ≥ 18 year-old.
- Diagnosis of chronic phase CML according to WHO 2016 criteria with a typical BCR::ABL1 rearrangement (e13a2 or e14a2)
- Duration of treatment by Imatinib ≥ 4 years / ITK2G ≥ 3 years /Imatinib and ITK2G ≥ 4 years and no change of TKI or decrease in dosage in the last 6 months prior to inclusion
- Deep Molecular Response (DMR) duration ≥ 1 year
- Absence of contraindication to the continuation of the same TKI for 12 months at the same dosage according to international recommendations nd the PCR of each TKI:
Imatinib (≥ 300 mg/j) Dasatinib (≥ 50 mg/j) Nilotinib (≥ 300 mg/j) Bosutinib (≥ 200 mg/j)
- Patient not participating in another interventional study for the duration of the interventional study
- Sexually active men should use effective contraception when taking Dasatinib
- Having an health insurance
- Having signed the consent form
Non-Inclusion Criteria:
- Patients with progressive severe pathology of poor prognosis immediately compromising participation in the entire study and/or with uncontrolled chronic pathology
- ECOG ≥ 3
- Prior resistance to TKI
- Patients who have already experienced an attempt of TKI cessation
- Patients with a malignant tumour that has been treated with chemotherapy within 2 months of inclusion or undergoing chemotherapy or that will be treated with post-inclusion chemotherapy
- Protected person
- Pregnant women or women of childbearing age without appropriate contraceptive measures
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05753384
Start Date
December 1 2023
End Date
December 1 2029
Last Update
July 29 2024
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu Angers
Angers, France
2
Ch Annecy
Annecy, France
3
Ch Bayonne
Bayonne, France
4
Chu Brest
Brest, France