Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL

This is a three-arm, multicenter, randomized controlled trial. Eligible participants will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio. Induction regimens: Arm A: Teniposide + orelabrutinib + rituximab + methotrexate (MTX) + dexamethasone, administered in 21-day cycles. Arm B: Orelabrutinib + rituximab + MTX + dexamethasone, administered in 21-day cycles. Arm C: Rituximab + MTX + dexamethasone, administered in 21-day cycles. Participants achieving complete response (CR) or unconfirmed complete response (CRu) post-induction will procee

Trial Details

NCT ID
NCT07185373
Phase
PHASE2 / PHASE3
Sponsor
Huashan Hospital
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Teniposide
  • Orelabrutinib
  • MTX
  • Rituximab (R)
  • Dexamethasone
Locations (sample)
  • Beijing, China|39.9075,116.39723
  • Beijing, China|39.9075,116.39723
  • Chengdu, China|30.66667,104.06667
  • Fuzhou, China|26.06139,119.30611
  • Guangzhou, China|23.11667,113.25

Key Eligibility Criteria

  • No prior systemic treatment for primary central nervous system lymphoma
  • Pathologically confirmed as diffuse large B-cell lymphoma subtype; with sufficient residual surgical specimens remaining after meeting the needs fo…
  • Aged 18-75 years (inclusive)
  • ECOG performance status ≤3

For full eligibility, visit ClinicalTrials.gov.

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