A Study on the Withdrawal of Second-generation Tyrosine K... | NCT05341050

Studies
A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML

NCT05341050

Sponsor

xuna

Status

Unknown status

Last Update Posted

Apr 22, 2022Actual

Enrollment

260Estimated

Phase

Not provided

Conditions

MMR on 12 Month

Interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

May 31, 2026Estimated

First Submitted Date

Apr 9, 2022

First Submission Date that Met QC Criteria

Apr 21, 2022

First Posted Date

Apr 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2022

Last Update Posted Date

Apr 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

260Estimated

Label	Type	Description	Intervention Names
patients with Ph+ CML-CP			Drug: TKI

Name	Type	Description	Arm Group Labels	Other Names
TKI	Drug	halve dose of 2G-TKI for 12 months and then withdrawal for 12 months	patients with Ph+ CML-CP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MMR(BCR/ABL IS<0.1%) on 24 months	Continue to treat patients at half-dose for 12 months, then stop for 12 months	24 months

Secondary Outcomes

Measure	Description	Time Frame
MRFS	Molecular relapse free survival in 24 months	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female over 18 years
Patients diagnosed as Ph+ (or Ph- but PCR-positive for BCR-ABL) CML-CP
Patients have received one of the second-generation TKIs (nilotinib, dasatinib) for at least 3 years
Patients have maintained MMR (BCR/ABL IS<0.1% or more) at least 2 years
in the past 24 months, at least three times recent molecular reactions have confirmed MMR
Patients have signed the informed consent

Exclusion Criteria:

patients with the presence or history of T315I mutation
patients with the presence of rare unquantifiable atypical transcripts
Patients with comorbid cardiovascular disease or a history of severe cardiovascular disease
patients have history of accelerated or blast phase, or suspected blast disease
patients have received allogeneic hematopoietic stem cell transplantation
patients have severe abnormal liver and kidney function (ALT > upper limit of normal, AST > 3 times normal upper line, glomerular filtration rate < 50%)
patients combined with other tumors or a history of other malignancies ECOG score>3
Two-line abnormality in the patient's blood routine examination
women is pregnant or nursing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients who have been diagnosed with CML-CP and are older than 18 years

Sampling Method

Non-Probability Sample