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)

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Page 1 of 5 (20 locations)

1

Chu Angers

Angers, France

2

Ch Annecy

Annecy, France

3

Ch Bayonne

Bayonne, France

4

Chu Brest

Brest, France

Discontinuation of TyrosIne Kinase Inhibitors (TKI) in Chronic Myeloid Leukemia (CML) and Impact on the Immune System | DecenTrialz