Orelabrutinib Combined With Obinutuzumab and Short-Course Venetoclax in Patients With Treatment-Naïve Mantle Cell Lymphoma (MCL)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University

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

Treatment groups

39 Participants
are divided into 1 treatment group