A Practical Clinical Study Comparing the Fixed-cycle Regi... | NCT06476899

Studies
A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy

NCT06476899

Sponsor

Fei Li

Status

Not yet recruiting

Last Update Posted

Jun 27, 2024Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

CLL/SLL

Interventions

orelabrutinib
FCR/BR
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

Jun 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

Jul 24, 2024Estimated

Primary Completion Date

Mar 26, 2026Estimated

Completion Date

Dec 26, 2026Estimated

First Submitted Date

Jun 19, 2024

First Submission Date that Met QC Criteria

Jun 21, 2024

First Posted Date

Jun 27, 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

Jun 21, 2024

Last Update Posted Date

Jun 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fixed regimen	Experimental	orelabrutinib + FCR/BR	Drug: orelabrutinib Drug: FCR/BR
Control	Active Comparator	BTKi chosen by doctors	Drug: BTK inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
orelabrutinib	Drug	orelabrutinib tablets	Fixed regimen
FCR/BR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TTNTD rate at 30 months	The proportion of time from the start of treatment to the start of the next treatment or death over a period of 30 months	30 months

Secondary Outcomes

Measure	Description	Time Frame
PFS	The time from the start of treatment to the point when the disease progression or death is confirmed by the investigator	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 70 years, with no gender restrictions;
Patients with CLL/SLL who meet the iwCLL2018 diagnostic criteria;
Indications for treatment
ECOG performance score of 0-2;
Patients are untreated or have not received standardized treatment
Before the trial screening, the subject or their legal representative voluntarily signs a written informed consent form, indicating that they understand the purpose of the study and the necessary research steps, and are able to comply with the protocol and follow-up.

Exclusion Criteria:

Has been diagnosed or treated for malignancies other than CLL (including active central nervous system lymphoma) within the past year;
there is clinical evidence of Richter transformation;
Participant cannot receive or plan to receive another treatment during study participation
Other conditions that the investigator considers inappropriate for participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000729508	orelabrutinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided