A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Com… (NCT07719855) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Combined With Obinutuzumab and Lenalidomide Versus Obinutuzumab Plus Chemotherapy for Treatment-Naive Follicular Lymphoma
China652 participantsStarted 2026-07
Plain-language summary
This study intends to conduct a prospective, multicenter, open-label, randomized controlled clinical trial to systematically evaluate the efficacy and safety of the orelabrutinib plus obinutuzumab and lenalidomide (RO2) regimen versus the obinutuzumab-combined chemotherapy (O-chemo) regimen in patients with previously untreated follicular lymphoma. The primary observation is whether the RO2 regimen can maintain or improve therapeutic efficacy while significantly reducing hematological toxicities and other related adverse reactions, so as to provide a novel therapeutic option for improving the prognosis and quality of life of patients with follicular lymphoma (FL).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects with histopathologically confirmed follicular lymphoma (FL) Grade 1-3A;
. Subjects who have never received prior anti-lymphoma therapy;
. Age ≥ 18 years old;
. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
. Adequate bone marrow, hepatic and renal function, defined as:
Exclusion criteria
. Uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival
Timeframe: From enrollment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (a maximum of 6 years)
. Abnormal laboratory parameters at screening (unless attributed to follicular lymphoma):
. Absolute neutrophil count \< 1.5 × 10⁹/L
. Platelet count \< 80 × 10⁹/L; if bone marrow involvement is present, platelet count \< 50 × 10⁹/L
. Alanine transaminase (ALT) or aspartate transaminase (AST) \> 2 × upper limit of normal (ULN); alkaline phosphatase (AKP) or bilirubin \> 1.5 × ULN
. Serum creatinine \> 1.5 × ULN OR estimated glomerular filtration rate (eGFR) \< 40 mL/min/1.73 m² (calculated via the Cockcroft-Gault equation or Modification of Diet in Renal Disease \[MDRD\] equation)
. Human immunodeficiency virus (HIV)-positive subjects.
. Left ventricular ejection fraction (LVEF) \< 50%.