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RECRUITING
NCT06554561
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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.

Official title: The Safety and Efficacy of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma : A Prospective, Multicenter, Phase I/II Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2024-08-31

Completion Date

2029-08-31

Last Updated

2024-08-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

Pomalidomide

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.

DRUG

Rituximab

375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 4-6 cycles will be prescribed.

DRUG

Methotrexate

3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 4-6 cycles will be prescribed.

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hanzhou, Zhejiang, China