Withdrawal or Reduction TKIs in CML-CP

• Conditions: MMR on 12 Month
• Interventions: Drug: withdrawal TKIs or halve TKIs

• Registration Number: NCT04143087
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

Compare MMR on 12 month treated with half TKIs(including imatinib, dasatinib, and nilotinib) or TKIs withdrawal.

Detailed Description

1. Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receive effective Tyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 5 years, and patients with BCR/ABLIS continuous negative in the last 18 months were randomly admitted to maintain the original effective TKI by half or stop taking .

2. Q-pcr detected BCR/ABLIS in peripheral blood once every month, once every two months after half a year, and continuously monitored for 12 months.

3. If the patients detected molecular recurrence (loss of MMR, BCR/ABLIS \> 0.1%), the original dose of TKI should be administered again.

Study Timeline

• Study Start: 2019-10-23
• Study First Submitted: 2019-10-26
• Study First Submitted QC: 2019-10-26
• Study First Posted: 2019-10-29
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age 18-70 years old, gender is not limited;
2. Diagnosed CML chronic phase and effective TKI(including imatinib, dasatinib, and nilotinib) was continued for more than 5 years
3. Q-PCR monitored BCR/ABLIS duration < 0.0032% in the last 18 months
4. Informed consent of the patient or his legal representative

Exclusion Criteria

1. Patients had history of CML-AP or CML-BC
2. CML patients with previous or current ABL kinase mutations
3. CML Patients who have received allogeneic hematopoietic stem cell transplantation
4. CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy)
5. Woman who is pregnant or nursing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
halve TKIs	withdrawal TKIs or halve TKIs	-
Withdrawal TKIs	withdrawal TKIs or halve TKIs	-

Primary Outcome Measures

Name	Time	Method
MMR(BCR/ABL IS<0.01) on 12 moth	12 moth	Half dose TKIs or discontinue TKIs treatment

Trial Locations

Locations (1)

NanfangH; 🇨🇳 Guangzhou, Guangdong, China