About this trial
This study aims to evaluate the safety and efficacy of orelabrutinib (O) in combination with obinutuzumab (G) and short-course venetoclax (V) in patients with treatment-naïve MCL.
Eligibility criteria
Qualifiers
Voluntarily participate and sign the informed consent form;
Age ≥ 18 years, male or female;
Life expectancy ≥ 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Patients with ECOG 3 may be enrolled only if the decline in performance status is attributed to the underlying disease and the investigator determines that they may benefit from the treatment;
Disqualifiers
Received prior treatment for lymphoma within 2 weeks before study enrollment;
Uncontrolled hypertension (defined as blood pressure that remains uncontrolled after at least 4 weeks of treatment with a reasonable and tolerable regimen of 3 or more antihypertensive agents [including diuretics] at adequate doses, or requiring 4 or more antihypertensive agents to achieve adequate control);
Uncontrolled congestive heart failure within 6 months prior to screening (New York Heart Association [NYHA] Class III [moderate] or Class IV [severe] cardiac disease);
Left ventricular ejection fraction (LVEF) < 50%;
Trial design
Treatments tested in this trial
- Orelabrutinib
- Obinutuzumab
- Venetoclax