Rituximab, Acalabrutinib, and Durvalumab (RAD) in Primary CNS Lymphoma.

Sponsor
National Health Research Institutes, Taiwan
Study ID
NCT04688151
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Primary Central Nervous System Lymphoma (PCNSL)

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — 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

Study Details

To evaluate the safety and tolerability and determine the recommended phase 2/phase 3 dose of RAD regimen in PCNSL

Key Dates

Start date
Feb 22, 2021
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose level 1,Dose level 2
    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

Primary Outcome Measure

MTD of acalabrutinib [ Time Frame: From date of registration until the date of definition of MTD of first documented progression or date of death from any cause, whichever came first, assessed up to 28 weeks. ]

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