Clinical trial NCT05341050: A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MMR on 12 Month
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who have been diagnosed with CML-CP and are older than 18 years

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: MMR(BCR/ABL IS<0.1%) on 24 months
timeFrame: 24 months
Secondary outcomes:
measure: MRFS
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanfangH
state: Guangdong
city: Guangzhou
country: China
facility: NanfangH
state: Guangdong
Study officials:
References: