Discontinuation of TyrosIne Kinase Inhibitors (ITK) in Chronic Myeloid Leukemia (LMC) and Impact on the Immune System: a Randomized Comparative Study of Two Therapeutic Strategies

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 associated with moderate, chronic and sometimes severe adverse effects. The ability to permanently stop treatment with TKI has thus become a major goal in CML to prevent the occurrence of adverse events, improve quality of life and reduce the general cost of the treatment; we talk about Treatment Free Remission (TFR). It now remains to be demonstrated in a comparative prospective study that a strategy of de-escalation of the TKI treatment dose before treatment discontinuation optimizes TFR results. At the same time, it is possible to reduce adverse reactions and improve the quality of life of patients. In this context, the investigator propose to conduct a randomized clinical trial including CML patients, allowing to compare the results of TFR at 24 months between a sudden stop of treatment after a maintenance phase of dosage for 12 months and a de-escalation arm of dose (dosage reduced by 50%) for 12 months before stopping. A secondary immunological translational objective of this project will be to compare the quantitative and qualitative evolution of innate CD8 T cells between the 2 arms (abrupt cessation of ITK treatment versus progressive withdrawal) and look for a predictive innate CD8 T cells blood signature at the time of stopping treatment of a successful TFR in both arms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
France
Chu Angers
RECRUITING
Angers
Ch Annecy
ACTIVE_NOT_RECRUITING
Annecy
Ch Bayonne
RECRUITING
Bayonne
Chu Brest
RECRUITING
Brest
CH Brive la Gaillarde
RECRUITING
Brive-la-gaillarde
Ch Chambery
ACTIVE_NOT_RECRUITING
Chambéry
CHI Creteil
RECRUITING
Créteil
Ch La Rochelle
RECRUITING
La Rochelle
Chu Lille
RECRUITING
Lille
CHU Limoges
RECRUITING
Limoges
Centre Léon Bérard
RECRUITING
Lyon
Ch Mont de Marsan
RECRUITING
Mont-de-marsan
Chu Nancy
ACTIVE_NOT_RECRUITING
Nancy
Chu Nantes
RECRUITING
Nantes
Hopital Prive Du Confluent
ACTIVE_NOT_RECRUITING
Nantes
Ch Perigueux
RECRUITING
Périgueux
Chu Poitiers
RECRUITING
Poitiers
Oncopole Toulouse
RECRUITING
Toulouse
Chu Tours
RECRUITING
Tours
CH Versailles
RECRUITING
Versailles
Contact Information
Primary
Emilie Cayssials-Caylus, Dr
emilie.cayssials@chu-poitiers.fr
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Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 140
Treatments
Experimental: continued treatment with TKI at 50% dose reduction
continued treatment with TKI at 50% dose reduction compared to dosing received at randomization and then stopped treatment 12 months after randomization
Active_comparator: continuation of TKI treatment without dose change
continued treatment with TKI at same dose compared to dosing received at randomization and then stopped treatment 12 months after randomization
Sponsors
Leads: Poitiers University Hospital

This content was sourced from clinicaltrials.gov