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

Not Applicable

Recruiting

• Conditions: CML
• Interventions: Drug: Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment

• Registration Number: NCT05926128
• Lead Sponsor: Fundaleu

Brief 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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2022-06-01
• Study First Submitted: 2022-06-02
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-29
• Last Update Submitted: 2023-06-29
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CML patient TKI discontinuation study	Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment	Treatment free remission in patients with chronic myeloid leukemia in chronic phase who achieved deep molecular response with tyrosine kinase inhibitors

Primary Outcome Measures

Name	Time	Method
Molecular relapse free survival during 24 months	24 months	Molecular relapse free survival, defined as the time from the start of TKI interruption until the loss of the MMR.; RQ PCR (IS) \>0.1% BCR ABL will be considered as loss of MMR

Secondary Outcome Measures

Name	Time	Method
Treatment-free survival during 24 months	24 months	Treatment-free survival , defined as the time from the start of TKI interruption to the restart of the TKI.

Trial Locations

Locations (1)

FUNDALEU; 🇦🇷 Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina