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

Fei Li

Status and phase: Not yet enrolling; Phase 2

Conditions: CLL/SLL

Treatments: Drug: BTK inhibitor; Drug: FCR/BR; Drug: orelabrutinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06476899

PragmatiCLL

Details and patient eligibility

About

Prospective, interventional, and practical clinical studies

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Fixed regimen

Experimental group

Description:

orelabrutinib + FCR/BR

Treatment:

Drug: orelabrutinib

Drug: FCR/BR

Control

Active Comparator group

Description:

BTKi chosen by doctors

Treatment:

Drug: BTK inhibitor