Clinical trial · Interventional
AI-Driven Treatment Strategy vs Pola-R-CHP in Untreated LBCL
A Study to Evaluate the Efficacy and Safety of an AI-Driven Treatment Strategy Versus Pola-R-CHP in Patients With Previously Untreated Large B-Cell Lymphoma
NCT07594899CI-TRIAL-00111995GUIDANCE-10not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, open-label, multicenter, randomized controlled study in participants with previously untreated large B-cell lymphoma. 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 Pola-R-CHP. In the experimental arm, participants will receive either genotype-guided targeted agents in combination with Pola-R-CHP or Pola-R-CHP combined with glofitamab, according to their AI-defined risk group and molecular features. Participants in the control arm will receive Pola-R-CHP. The study will evaluate the efficacy and safety of the AI-guided treatment strategy compared with Pola-R-CHP.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Large B-Cell Lymphoma (LBCL) | — | UNRESOLVED | — |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Glofitamab | Drug | Glofitamab | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Polatuzumab Vedotin | Drug | Polatuzumab Vedotin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP
- description
- Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2, doxorubicin 50 mg/m² IV on Day 2, and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of the first 21-day cycle. For the remaining five cycles, participants will receive standard Pola-R-CHP in combination with one of the following: zanubrutinib 160 mg BID PO on Days 1-21, lenalidomide 25 mg/day PO on Days 2-11, decitabine 10 mg/m²/day IV on Days -5 to -1, or glofitamab administered IV 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 8 of Cycles 3-6. Each treatment cycle is 21 days.
- interventionNames
- Drug: Polatuzumab Vedotin
- Drug: rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Prednisone
- Drug: Zanubrutinib
- Drug: Lenalidomide
- Drug: Decitabine
- Drug: Glofitamab
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-75 years with comprehensive geriatric assessment stratified as fit * Previously untreated participants with CD20-positive LBCL (without central nervous system involvement) * ECOG Performance Status of 0, 1, or 2 * After 1 cycle of Pola-R-CHP, classified as intermediate-risk or high-risk by AI-based multimodal stratification * Life expectancy ≥ 3 months * At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters) * The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research. * Anti-lymphoma drugs have not been used before (except glucocorticoids) Exclusion Criteria: * Prior solid organ transplantation or SCT * Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina * History or presence of an abnormal ECG that is clinically significant in the investigator's opinion * Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma): * Absolute neutrophil count \<1.0 × 10⁹/L. * Platelet count \<75 × 10⁹/L * Serum AST and ALT ≥ 2.5 x ULN * Total bilirubin ≥ 1.5 x ULN * Serum creatinine clearance \< 30 mL/min (using Cockcroft-Gault formula) * Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety * Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology)：Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HbsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing every month and appropriate antiviral therapy as indicated * Positive test results for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing)：Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA * Participants with a history of progressive multifocal leukoencephalopathy * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 months after final dose of treatment * Participants with uncontrolled coagulation disorders, connective tissue diseases, severe infectious diseases * Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, would affect the patient's participation in the study
References
Publications (0)
Data not yet available
No reference posted for this study.