Rituximab, Acalabrutinib, and Durvalumab (RAD) in Primary CNS Lymphoma.
NCT04688151 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2025-05-22
Summary
To evaluate the safety and tolerability and determine the recommended phase 2/phase 3 dose of RAD regimen in PCNSL
Conditions
- Primary Central Nervous System Lymphoma (PCNSL)
Interventions
- DRUG
-
Dose level 1:Rituximab 375mg/m2 infusion once every 4 weeks for 8 cycles Acalabrutinib 100mg PO once every day Durvalumab 1500mg infusion once every 4 weeks Dose level 2:Rituximab 375mg/m2 infusion once every 4 weeks for 8 cycles Acalabrutinib 100mg PO twice every day Durvalumab 1500mg infusion once every 4 weeks Expansion:Determined by the result of the dose escalation phase
Sponsors & Collaborators
-
National Taiwan University Hospital
collaborator OTHER -
National Cheng-Kung University Hospital
collaborator OTHER -
China Medical University Hospital
collaborator OTHER -
Chang Gung Memorial Hospital
collaborator OTHER -
National Health Research Institutes, Taiwan
lead OTHER
Principal Investigators
-
Shang-Ju Wu, M.D · National Taiwan University Hospital, Taipei, Taiwan
-
Su-Peng Yeh, M.D · China Medical University Hospital
-
Kwang-Yu Chang, M.D · National Cheng Kung University Hospital,Taiwan
-
Ming Chung Wang, M.D · Chang Gung Memorial Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-22
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Taiwan
Study Locations
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