Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of OR-MTX chemotherapy(Orelabrutinib, Rituximab and Methotrexate)as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate is the primary endpoint.

Eligibility criteria

Qualifiers

Histologically confirmed Primary Central Nervous System (CNS) lymphoma Age range 18-75 years old.

Eastern Cooperative Oncology Group performance status 0 to 3.

Previously untreated. Patients treated with steroid alone are eligible.

Measurable disease was defined as at least ≥1.0cm in short-diameter by MRI.

Disqualifiers

Patient with systemic, non-CNS lymphoma metastatic to the CNS.

Patient is concurrently using other approved or investigational antineoplastic agents.

Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseases include but not limited to HIV.

Patient is allergic to components of the study drug.

Trial design

Treatments tested in this trial

  • Orelabrutinib
  • Rituximab
  • Methotrexate

Treatment groups

28 Participants
are divided into 1 treatment group

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting310009, Hanzhou, ZhejiangChinaChina