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

Launched by FEI LI · Jun 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The goal is to compare a specific combination of medications, including Orelabrutinib, to see how well it works compared to standard single-drug treatments. This research is meant to help improve treatment options for patients with these conditions.

To be eligible for the study, participants need to be between 18 and 70 years old and should have been diagnosed with CLL or SLL. They should not have received any previous standard treatments and must have a good performance score, meaning they are able to carry out daily activities. Participants will need to provide informed consent, which means they understand the study and agree to take part. If you join the trial, you can expect regular follow-ups and monitoring throughout the study. It's important to note that individuals with other active cancers or certain health conditions may not be able to participate. This trial is currently not recruiting participants, but it aims to gather valuable information that could lead to better treatments in the future.

Gender

ALL

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