Withdrawal or Reduction TKIs in CML-CP

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

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

Study Overview

• Status: Recruiting
• Conditions: MMR on 12 Month
• Intervention / Treatment: Drug: withdrawal TKIs or halve TKIs

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

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

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • NanfangH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diagnosed CML chronic phase,Age 18-70 years old,gender is not limited

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Withdrawal TKIs	Drug: withdrawal TKIs or halve TKIs; Stop TKIs or treated by half TKIs
halve TKIs	Drug: withdrawal TKIs or halve TKIs; Stop TKIs or treated by half TKIs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MMR(BCR/ABL IS<0.01) on 12 moth	Half dose TKIs or discontinue TKIs treatment	12 moth

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 26, 2019
• First Submitted That Met QC Criteria: October 26, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TKIs-cml-002

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