NCT05926128

Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase

Prospective Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Achieved Deep Molecular Response With Tyrosine Kinase Inhibitors in Real Life Setting in Argentina - (Argentine Stop Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Fundaleu · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The principal aim of this study is to evaluate complete molecular remission in patients with chronic myeloid leukemia (CML) in deep molecular response after stopping tyrosine kinase inhibitor (TKI) treatment. The second aim is to characterize the immunological status of patients with CML at the time of TKI interruption and then at 3 months after the interruption.

Detailed description

ARGENTINA STOP TRIAL is a multicentre, open-label, uncontrolled trial to estimate the persistence of molecular remission in patients with chronic phase Chronic Myeloid Leukemia (CML) in Deep Molecular Response after stopping Tyrosine Kinase Inhibitor (TKI) Primary Objective: \- To identify the proportion of patients who continue on Major Molecular Response after discontinuing treatment with TKI. Secondary objectives: * To characterize the immunological status of patients with CML at the time of interruption and then at 3 and 12 months after the interruption. Tertiary objective: To evaluate the pharmacoeconomic impact of interrupting the treatment.

Conditions

• CML

Interventions

Type	Name	Description
DRUG	Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment	Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment with a scheduled molecular monitoring until month 24.

Timeline

• Start date: 2019-02-01
• Primary completion: 2022-06-01
• Completion: 2025-01-01
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

1 site across 1 country: Argentina