Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

This is a single- arm, open-label, multicenter, phase II study to evaluate Acalabrutinib plus Rituximab for the treatment of elderly or low- to intermediate-risk younger untreated mantle cell lymphoma

Eligibility criteria

Qualifiers

Age ≥18 years.

Histologically confirmed CD20+ mantle cell lymphoma.

No prior anti-lymphoma treatment.

Ann Arbor stage II-IV.

Disqualifiers

Participants with tumor burden reduction prior to stem cell transplantation.

History of active lymphoma central nervous system (CNS) involvement, leptomeningeal disease, or spinal cord compression.

Any disease evidence deemed by the investigator to be detrimental to the patient's participation or likely to affect protocol adherence (e.g., severe or uncontrolled systemic disease, including uncontrolled hypertension or kidney transplant).

History of progressive multifocal leukoencephalopathy (PML) or current diagnosis of PML.

Trial design

Treatments tested in this trial

  • Acalabrutinib
  • Rituximab

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators