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

ConditionCLL/SLL

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorFei Li

About this trial

Prospective, interventional, and practical clinical studies

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

orelabrutinib
Drug
orelabrutinib tablets
FCR/BR
Drug
FCR/BR
BTK inhibitor
Drug
BTK inhibitor choose by physican

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Fixed regimenExperimental treatment 2 interventions

Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

30 months

Secondary outcomes

PFS

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

Time frame

3 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fei Li

Lead sponsor

The First Affiliated Hospital of Nanchang University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: