The Real World Study of BTK Inhibitor in the Treatment of... | NCT06557304

Studies
The Real World Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China

NCT06557304

Sponsor

Peking University People's Hospital

Status

Not yet recruiting

Last Update Posted

Aug 21, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Interventions

BTK inhibitor

Countries

Not provided

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Estimated

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Dec 30, 2027Estimated

First Submitted Date

Aug 13, 2024

First Submission Date that Met QC Criteria

Aug 13, 2024

First Posted Date

Aug 16, 2024Actual

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

Aug 19, 2024

Last Update Posted Date

Aug 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China

Detailed Description

Not provided

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BTK inhibitor	Drug	patients with treatment naive or R/R CLL who treatment with BTK inhibitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	OS is defined as the time from the starting date of BTK inhibitor to the date of death due to any cause.	up to five years

Secondary Outcomes

Measure	Description	Time Frame
Time to Next Therapy (TTNT)	The TTNT will be calculated as the difference between BTK inhibitor initiation date and initiation date of the first next therapy for CLL	up to two years
Adverse Events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged ≥18 years old
Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL [International Workshop on Chronic Lymphocytic Leukemia] criteria)；
Treatment-naïve OR Refractory Recurrence CLL patients who were initiated on BTK inhibitor;
Prior or current use of BTK inhibitor for ≥3 months
At least one follow-up was recorded during BTK inhibitor treatment

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

Investigators participating in this observational study should include all patients with CLL who initiated treatment with BTK inhibitor over the period from Dec. 1st, 2017 to the present, regardless of the treatment status at the time of inclusion. Thus, at the time of enrolment and retrospective data collection, patients may still be on treatment or have stopped treatment for any reason.

Sampling Method

Non-Probability Sample