Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06476899

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

Prospective, interventional, and practical clinical studies

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

CLL/SLL

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orelabrutinib

Drug

orelabrutinib tablets

FCR/BR

Drug

FCR/BR

BTK inhibitor

Drug

BTK inhibitor choose by physican

Primary outcomes

  1. TTNTD rate at 30 months

    Time frame: 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

Secondary outcomes

  1. PFS

    Time frame: 3 years

    The time from the start of treatment to the point when the disease progression or death is confirmed by the investigator

Sponsors and collaborators

Lead sponsor

Fei Li

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.