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

A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy in Previously Untreated CLL/SLL

Prospective, interventional, and practical clinical studies

Study Overview

• Status: Not yet recruiting
• Conditions: CLL/SLL
• Intervention / Treatment: Drug: orelabrutinib; Drug: FCR/BR; Drug: BTK inhibitor

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fixed regimen; orelabrutinib + FCR/BR	Drug: orelabrutinib; orelabrutinib tablets; Drug: FCR/BR; FCR/BR
Active Comparator: Control; BTKi chosen by doctors	Drug: BTK inhibitor; BTK inhibitor choose by physican

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fei Li

Study record dates

Study Major Dates

• Study Start (Estimated): July 24, 2024
• Primary Completion (Estimated): March 26, 2026
• Study Completion (Estimated): December 26, 2026

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PragmatiCLL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No