A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma
NCT Number: NCT06554561
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: PCNSL
Interventions: DRUG: Pomalidomide|DRUG: Rituximab|DRUG: Methotrexate
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 43
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2029-08-31
Locations: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hanzhou, Zhejiang, 310009, China

Summary:
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.

Primary Outcome Measures: MTD, MTD of pomalidomide when given in combination with rituximab and methotrexate determined by dose-limiting toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, 21days|Objective response rate(ORR), The objective response rate is defined as the proportion of patients with a response of complete response(CR) or partial response(PR)., 4 cycles of threatment
Secondary Outcome Measures: Progression free survival, From date of patients sign informed consent until the date of progression or death or the date of last follow-up time, whichever came first, assessed up to 3 years, Time from registration to progression or death due to PCNSL, assessed up to 2 years|Overall survival, From date of patients sign informed consent until the date of progression or death or the date of last follow-up time, whichever came first, assessed up to 3 years, Time from registration to death due to any cause, assessed up to 3 years
Other Outcome Measures: pomalidomide levels in the CNS, Based on pomalidomide levels in CSF at different time points, Up to day 3 of course 2|pomalidomide levels in the Blood, Based on pomalidomide levels in blood at different time points, Up to day 3 of course 2