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

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 treatme

Trial Details

NCT ID
NCT06554561
Phase
PHASE1 / PHASE2
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Pomalidomide
  • Rituximab
  • Methotrexate
Locations (sample)
  • Hanzhou, Zhejiang, China

Key Eligibility Criteria

  • Histopathologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL).
  • The lesions were confined to the central nervous system, including the brain, spinal cord, eyes and meninges.
  • Through physical examination, imaging examination (including CT, MRI, PET-CT, etc.) and bone marrow puncture examination, it was confirmed that no …
  • Patients who have not previously received chemotherapy or radiotherapy (except those with dexamethasone less than 10mg/ day (or equivalent dose) an…

For full eligibility, visit ClinicalTrials.gov.

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