A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT06554561
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • PCNSL

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pomalidomide — DRUG
    3-5mg d1-d14 for 4-6 cycles, every 21 days as induction/consolidation chemotherapy, Then 3-5mg d1-d14 for 12 cycles, every 28 days as maintenance treatment.
  • Rituximab — DRUG
    375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 4-6 cycles will be prescribed.
  • Methotrexate — DRUG
    3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 4-6 cycles will be prescribed.

Study Details

This is a prospective, multicenter, single-arm, open Phase Ib/II clinical study to explore the safety and efficacy of pomadomide in combination with rituximab and methotrexate (RPM) in newly diagnosed primary central nervous system lymphoma (PCNSL) subjects. The Phase I study is a dose escalation study, in which rituximab and methotrexate are fixed doses, and pomadomide is set into 3 dose groups: 3mg/d, 4mg/d and 5mg/d. In strict accordance with the "3+3" dose escalation principle, 3-6 subjects are to be recruited in each dose group, and each subject is to be observed for 1 cycle after treatment to determine MTD. Phase II study: RP2D is planned to be determined based on the Phase Ib study, with an additional 25 active participants enrolled to further evaluate efficacy and safety. Subjects with initial treatment of PCNSL who met the inclusion/exclusion criteria were screened, and after signing the informed consent letter, they received 4 courses of PRM regimen. The patients achieving CR or PR were consolidated by autologous transplantation consolidation regimen or the original regimen for 2 courses, and then were given pomadomide maintenance therapy for 12 cycles. Follow-ups should be taken up to the first 3 years.

Key Dates

Start date
Aug 31, 2024
Status verified
Aug 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2029

Study Design

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

Arms

  • Experimental: PRM treatment
    Experimental arm will be treated with PRM regimen (pomadomide in combination with rituximab and methotrexate) for 4 cycles as initiate induction. If the patients achieved complete remission（CR）or partial remission（PR）, They would be consolidated by autologous transplantation consolidation regimen or the original regimen for additional 2 courses, and then were given pomadomide maintenance therapy for 12 cycles.

Primary Outcome Measure

MTD [ Time Frame: 21days ]

Central Contacts