NCT05753384

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

Recruiting now Phase 3 Last updated 29 July 2024

What this trial tests

Phase 3 trial testing treatment of TKI in CML in Tyrosine Kinase Inhibitors in 140 participants. Currently enrolling.

Timeline

1 December 2023

Primary endpoint
1 December 2028

1 December 2029

Quick facts

Lead sponsor	Poitiers University Hospital
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	140
Start date	1 December 2023
Primary completion	1 December 2028
Estimated completion	1 December 2029
Sites	20 locations across France

Drugs / interventions tested

• treatment of TKI in CML — full drug profile →

Conditions studied

• Tyrosine Kinase Inhibitors — all drugs for Tyrosine Kinase Inhibitors →
• Chronic Myeloid Leukemia — all drugs for Chronic Myeloid Leukemia →

Sponsor

Poitiers University Hospital

Who can join

18 and older, any sex, with Tyrosine Kinase Inhibitors or Chronic Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exploration of treatment-free remission in CML, based on molecular monitoring.
   Zhang Z, Zhou X, Zhou X, Cheng Z, et al · · 2024 · cited 3× · PMID 38133525 · DOI 10.1002/cam4.6849