Withdrawal or Reduction TKIs in CML-CP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-23

Study Completion Date

2021-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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MMR on 12 Month

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Withdrawal TKIs

withdrawal TKIs or halve TKIs

Intervention Type DRUG

Stop TKIs or treated by half TKIs

halve TKIs

withdrawal TKIs or halve TKIs

Intervention Type DRUG

Stop TKIs or treated by half TKIs

Interventions

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withdrawal TKIs or halve TKIs

Stop TKIs or treated by half TKIs

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No