Withdrawal or Reduction TKIs in CML-CP

MMR on 12 Month Clinical Trial

Official title:

A Multicenter, Open-access Study of CML-CP Patients Treated With Effective TKIs at Least 5 Years and MR4.5(BCR/ABLIS<0.0032%) Maintenance More Than 18 Months Who Treatment With Half TKIs or Discontinue

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04143087
• Other study ID #: TKIs-cml-002
• Status: Recruiting
• Start date: October 23, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: xu na
• Phone: 18620698390
• Email: sprenaa[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• MMR on 12 Month

Intervention

Drug:
• withdrawal TKIs or halve TKIs
Stop TKIs or treated by half TKIs

Locations

Country	Name	City	State
China	NanfangH	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMR(BCR/ABL IS<0.01) on 12 moth	Half dose TKIs or discontinue TKIs treatment	12 moth