AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL

Sponsor
Ruijin Hospital
Study ID
NCT07717177
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Large B-Cell Lymphoma (LBCL)

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab Vedotin — DRUG
    Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
  • Rituximab (R) — DRUG
    Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
  • Zanubrutinib — DRUG
    Zanubrutinib PO will be administered as per the schedule specified in the respective arm.
  • Lenalidomide — DRUG
    Lenalidomide PO will be administered as per the schedule specified in the respective arm.
  • Glofitamab — DRUG
    Glofitamab IV infusion will be administered as per the schedule specified in the respective arm.

Study Details

This is a prospective, open-label, multicenter, randomized controlled study in older treatment-naive patients with LBCL. Participants will be stratified into different risk groups using an AI-based multimodal model. Those classified as intermediate- or high-risk will be randomized in a 1:1 ratio to receive either an AI-guided treatment strategy or ZR2. In the experimental arm, participants will receive polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen (polatuzumab vedotin, zanubrutinib, lenalidomide, and glofitamab), according to their AI-defined risk group. Participants in the control arm will receive ZR2. The study will evaluate the efficacy and safety of the AI-guided treatment strategy compared with ZR2.

Key Dates

First listed
Jul 21, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen
    Participants will receive zanubrutinib 160 mg BID orally (PO) on Days 1-21, lenalidomide 25 mg/day PO on Days 2-11, and rituximab 375 mg/m² intravenously (IV) on Day 1 of the first cycle. For the remaining five cycles, participants will receive either Pola-ZR2 or Pola-ZR-Glo. In the Pola-ZR2 regimen, participants will receive ZR2 in combination with polatuzumab vedotin 1.8 mg/kg IV on Cycle 2 Day 2 and on Day 1 of Cycles 3-6. In the Pola-ZR-Glo regimen, participants will receive zanubrutinib 160 mg BID PO on Days 1-21 of Cycles 1-6, lenalidomide 25 mg/day orally on Days 2-11 of Cycles 1-6, polatuzumab vedotin 1.8 mg/kg intravenously on Cycle 2 Day 2 and on Day 1 of Cycles 3-6, and glofitamab intravenously with step-up dosing of 2.5 mg on Cycle 2 Day 8, 10 mg on Cycle 2 Day 15, and 30 mg on Day 1 of Cycles 3-12. For participants receiving the ZR2 or Pola-ZR2 regimen, lenalidomide maintenance will be continued for 18 weeks after six cycles of treatment. Each treatment cycle is 21 days.
  • Active Comparator: ZR2
    Participants will receive zanubrutinib 160 mg BID orally (PO) on Days 1-21, lenalidomide 25 mg/day orally on Days 2-11, and rituximab 375 mg/m² intravenously (IV) on Day 1 of every 21-day cycle for 6 cycles.

Primary Outcome Measure

Progression-free survival [ Time Frame: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months) ]

Central Contacts

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