招募中 NCT06549595

Surovatamig (AZD0486)加利妥昔單抗在既往未治療的濾泡性淋巴瘤患者中的研究

淋巴瘤Phase IIIII 期

這是一項全球性、隨機、III期、多中心、開放標籤研究,評估Surovatamig (AZD0486)加利妥昔單抗組合與研究者選擇的3種標準免疫化療方案相比,在未治療FL的參與者中進行的療效、安全性和額外受益程度。

適應症:Untreated Follicular Lymphoma

收案條件

納入條件

  • Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
  • Histologically confirmed diagnosis of classic FL per WHO 2022 classification
  • ECOG performance status of 0 to 2
  • No prior systemic lymphoma-directed therapy
  • Need for systemic treatment meeting at least 1 GELF criteria
  • FDG-avid and measurable disease
  • Stage II to IV and FLIPI 2-5 \[Phase III only\]
  • Adequate liver, hematological, renal and cardiac function.

排除條件

  • Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
  • Contra-indication to BR, RCVP, and R-CHOP
  • Participants with or history of CNS lymphoma
  • History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety
  • Presence of \>5000 circulating lymphoma cells
  • Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment
  • Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。