Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05390749
Phase
PHASE2
Status
Unknown

Conditions

  • Primary Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Orelabrutinib — DRUG
    Orelabrutinib will be given as 150mg orally d1-d21 for 6 cycles,every 21 days for 1 cycle.
  • Pomalidomide — DRUG
    Pomalidomide will be given as 4mg d1-d14 for 4 cycles,every 21 days for 1 cycle.
  • Rituximab — DRUG
    Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol
  • Methotrexate — DRUG
    methotrexate 3.5g/m2 civ d1/cycle5-6

Study Details

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of sequential treatment regimens with RO-MTX after pomalidomide, orelabrutinib, rituximab (POR) in newly-diagnosed primary central nervous system lymphoma, and explore the feasibility of chemo-free treatment in PCNSL. The primary objective was the overall response rate (ORR; defined as partial response \[PR\] or better) after 4 cycles of POR.

Key Dates

Start date
Apr 11, 2022
Status verified
Apr 2022
Primary completion
Apr 1, 2024
Completion
Apr 1, 2026

Study Design

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

Arms

  • Experimental: POR-ROMTX
    The experimental arm will be treated with 4 cycles of POR regimen （Pomalidomide 4mg d1-d14, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). The response will be evaluated every 2 cycles. The patients with PD will drop out of the study.Patients with CR/PR/SD after 4 cycles of POR treatment will be treated with 2 cycles of RO-MTX regimen（methotrexate 3.5g/m2 civ d1, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle).

Primary Outcome Measure

overall response rate [ Time Frame: The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days ]

Central Contacts

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