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

This Study is a Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Drug Discontinuation After Dose Reduction in Ph+CML-CP Patients Threated With 2G-TKI.

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.

Study Overview

• Status: Recruiting
• Conditions: MMR on 12 Month
• Intervention / Treatment: Drug: TKI

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 Type: Observational
• Enrollment (Anticipated): 260

Contacts and Locations

• Study Contact: Name: xu na; Phone Number: 18620698390; Email: sprenaa@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Not yet recruiting
      • NanfangH
      • Contact: NanfangH na, doctor; Phone Number: 18620698390; Email: sprenaa@163.com
    • Guangzhou, Guangdong, China
      • Recruiting
      • NanfangH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who have been diagnosed with CML-CP and are older than 18 years

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with Ph+ CML-CP	Drug: TKI; halve dose of 2G-TKI for 12 months and then withdrawal for 12 months

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRFS	Molecular relapse free survival in 24 months	24 months

Collaborators and Investigators

• Sponsor: xuna

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): May 31, 2026

Study Registration Dates

• First Submitted: April 9, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TKIs-cml

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No