A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML

Recruiting

• Conditions: MMR on 12 Month
• Interventions: Drug: TKI

• Registration Number: NCT05341050
• Lead Sponsor: xuna

Brief Summary

patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years, continue to be treated with halved dose for 12 months, and then stop for 12 months.

Detailed Description

1.Patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years.

2。During the TKI reduction phase, the peripheral blood BCR/ABLIS was detected by Q-PCR every two months and continuously monitored for 12 months. In the TFR period, the peripheral blood BCR/ABLIS was detected once a month for the first 6 months; the peripheral blood BCR/ABLIS was detected once every two months for the next 6 months; after that, the peripheral blood BCR/ABLIS was detected once every three months.

3.If the patients detected molecular recurrence (loss of MMR, BCR/ABL IS\>0.1%),the original dose of 2G-TKI should be administered

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-04-01
• Study First Submitted: 2022-04-09
• Study First Submitted QC: 2022-04-21
• Last Update Submitted: 2022-04-21
• Study First Posted: 2022-04-22
• Last Update Posted: 2022-04-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Male or female over 18 years
2. Patients diagnosed as Ph+ (or Ph- but PCR-positive for BCR-ABL) CML-CP
3. Patients have received one of the second-generation TKIs (nilotinib, dasatinib) for at least 3 years
4. Patients have maintained MMR (BCR/ABL IS<0.1% or more) at least 2 years
5. in the past 24 months, at least three times recent molecular reactions have confirmed MMR
6. Patients have signed the informed consent

Exclusion Criteria

1. patients with the presence or history of T315I mutation
2. patients with the presence of rare unquantifiable atypical transcripts
3. Patients with comorbid cardiovascular disease or a history of severe cardiovascular disease
4. patients have history of accelerated or blast phase, or suspected blast disease
5. patients have received allogeneic hematopoietic stem cell transplantation
6. patients have severe abnormal liver and kidney function (ALT > upper limit of normal, AST > 3 times normal upper line, glomerular filtration rate < 50%)
7. patients combined with other tumors or a history of other malignancies ECOG score>3
8. Two-line abnormality in the patient's blood routine examination
9. women is pregnant or nursing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with Ph+ CML-CP	TKI	-

Primary Outcome Measures

Name	Time	Method
MMR(BCR/ABL IS<0.1%) on 24 months	24 months	Continue to treat patients at half-dose for 12 months, then stop for 12 months

Secondary Outcome Measures

Name	Time	Method
MRFS	24 months	Molecular relapse free survival in 24 months

Trial Locations

Locations (1)

NanfangH; 🇨🇳 Guangzhou, Guangdong, China