AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL
ConditionLarge B-Cell Lymphoma (LBCL)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70+
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Histologically-confirmed large B-cell lymphoma (without central nervous system involvement)
Aged ≥ 70 years old with comprehensive geriatric assessment stratified as unfit or frail, or those who decline immunochemotherapy.
After 1 cycle of ZR2, classified as intermediate-risk or high-risk by AI-based multimodal stratification
Eastern Cooperative Oncology Group Performance Status 0-2
Disqualifiers
Uncontrolled blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
uncontrollable or significant cardiovascular diseases, including but not limited to: Left ventricular ejection fraction<50% Cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy QTc prolongation with clinical significance, QTc interval>470ms (females) or 480ms (males), type 2 second-degree atrioventricular block or third-degree atrioventricular block
Patients with HbsAg positive are required to have HBV DNA<1.0×10^3 IU/ml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<1.0×10^3 IU/ml is required before entering the group
Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
Trial design
Treatments tested in this trial
- Polatuzumab Vedotin
- Rituximab (R)
- Zanubrutinib
- Lenalidomide
- Glofitamab
Treatment groups
112 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov