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

NCT06476899 | Not Yet Recruiting Phase 2

• 1 other identifier: PragmatiCLL
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective, interventional, and practical clinical studies

Conditions

CLL/SLL

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• PFS

  3 years

Study Arms (2)

Fixed regimen

EXPERIMENTAL

orelabrutinib + FCR/BR

Drug: orelabrutinib; Drug: FCR/BR

Control

ACTIVE COMPARATOR

BTKi chosen by doctors

Drug: BTK inhibitor

Interventions

orelabrutinib DRUG

orelabrutinib tablets

Fixed regimen

FCR/BR DRUG

FCR/BR

Fixed regimen

BTK inhibitor DRUG

BTK inhibitor choose by physican

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fei Li: lead

MeSH Terms

Interventions

orelabrutinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 27, 2024
• Study Start: July 24, 2024
• Primary Completion: March 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share