Brief Summary

This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

110

participants targeted

Target at P50-P75 for phase_2

Timeline

2mo left

Started Nov 2019

Longer than P75 for phase_2

Geographic Reach

4 countries

173 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.6 years study duration

Study Progress98%

Nov 2019Jun 2026

First Submitted

Initial submission to the registry

January 2, 2019

Completed

23 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed

10 months until next milestone

Study Start

First participant enrolled

November 8, 2019

Completed

6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

6.6 years

First QC Date

January 2, 2019

Last Update Submit

May 1, 2026

Conditions

Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive

Outcome Measures

Primary Outcomes (2)

Treatment-free remission (TFR)
The Kaplan Meier method will be used to estimate 2-year TFR along with a 95% confidence interval.
From date of TKI discontinuation to the date of the first event (molecular recurrence, hematologic relapse, cytogenetic relapse, re-initiation of TKI therapy, second malignant neoplasm, or death) or censoring, assessed up to 2 years
Major molecular remission (MMR/MR3)
For patients re-initiating tyrosine kinase inhibitor (TKI) therapy, the cumulative incidence of major molecular remission will be calculated from the time of re-initiating TKI therapy treating deaths prior to achieving major molecular remission as competing events.
Up to 1 year

Secondary Outcomes (1)

Clinical factors and laboratory correlates affecting persistence of MMR
Up to 36 months

Study Arms (1)

Basic Science (stop taking TKI, biospecimen collection)

EXPERIMENTAL

Patients stop taking TKI medication within 10 days after enrollment. Patients undergo peripheral blood collection to monitor loss of MMR every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3. Patients who lose their molecular remission may restart TKI medication and are monitored every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3.

Procedure: Biospecimen CollectionOther: Drug WithdrawnOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationDrug: Tyrosine Kinase Inhibitor