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

NCT ID: NCT06476899

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-24
• Study Completion Date: 2026-12-26

Brief Summary

Prospective, interventional, and practical clinical studies

Conditions

CLL/SLL

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fixed regimen

orelabrutinib + FCR/BR

Group Type: EXPERIMENTAL

orelabrutinib

Intervention Type: DRUG

orelabrutinib tablets

FCR/BR

Intervention Type: DRUG

FCR/BR

Control

BTKi chosen by doctors

Group Type: ACTIVE_COMPARATOR

BTK inhibitor

Intervention Type: DRUG

BTK inhibitor choose by physican

Interventions

orelabrutinib

orelabrutinib tablets

Intervention Type: DRUG

FCR/BR

FCR/BR

Intervention Type: DRUG

BTK inhibitor

BTK inhibitor choose by physican

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fei Li

OTHER

Sponsor Role: lead

Responsible Party

Fei Li

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

PragmatiCLL

Identifier Type: -

Identifier Source: org_study_id