Clinical trial · Interventional
A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1
An Open-Label, Multicentre, Randomized Phase II Non-Inferiority Trial Comparing 4 vs 6 Cycles of CHP (21-Day Intervals) Both Combined With 6 Cycles of Polatuzumab Vedotin and Rituximab in Previously Untreated Diffuse Large B-Cell Lymphoma Patients With IPI 0-1
- 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 an open-label, multicentre, randomized phase II non-inferiority trial aiming to compare the efficacy and safety of 4 versus 6 cycles of CHP (administered at 21-day intervals), both in combination with 6 cycles of polatuzumab vedotin and rituximab, in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and an International Prognostic Index (IPI) score of 0-1. The study's primary objective is to determine if shorter CHP duration can achieve comparable outcomes to the standard 6-cycle regimen when combined with polatuzumab vedotin and rituximab
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 |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | Interdigitating Dendritic Cell Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Polatuzumab Vedotin | Drug | Polatuzumab Vedotin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 4×Pola-RCHP followed by 2×Pola-R
- description
- Participants will receive: Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles. Rituximab: 375 milligrams per square meter (mg/m\^2) IV on Day 1 of every cycle for 6 cycles. Cyclophosphamide: 750 mg/m\^2 IV on Day 1 of every cycle for 4 cycles. Doxorubicin: 50 mg/m\^2 IV on Day 1 of every cycle for 4 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 4 cycles. This Pola-RCHP regimen is repeated for 4 cycles, followed by 2 cycles of Polatuzumab Vedotin and Rituximab.
- interventionNames
- Drug: Polatuzumab Vedotin
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Prednisone
- type
- ACTIVE_COMPARATOR
- label
- 6×Pola-RCHP
- description
- Participants will receive: Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles. Rituximab: 375 milligrams per square meter (mg/m\^2) IV on Day 1 of every cycle for 6 cycles. Cyclophosphamide: 750 mg/m\^2 IV on Day 1 of every cycle for 6 cycles. Doxorubicin: 50 mg/m\^2 IV on Day 1 of every cycle for 6 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 6 cycles. This regimen is repeated for 6 cycles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed, untreated, biopsy-proven CD20 positive diffuse large B-cell lymphoma (DLBCL) * Age ≥18yo and ≤80yo at the time of signing consent * International Prognostic Index (IPI) score 0-1 * ECOG 0-2 * Have measurable disease on a pre-chemotherapy PET/CT, defined as at least one bi-dimensionally measurable nodal lesion of \>1.5cm in longest dimension, or at least one bi-dimensionally measurable extranodal lesion of \>1.0cm in longest dimension * Life expectancy greater than or equal to (\>/=)12 months * Left ventricular ejection fraction (LVEF) \>/= 50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) * Adequate hematologic function * Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from donating eggs. * Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm. Exclusion Criteria: * Patients with central nervous system or primary mediastinal lymphoma, and patients with transformed lymphoma. * Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc. * Pregnant or lactating women. * Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV; positive by RNA polymerase chain reaction \[PCR\]) infection. * Patients with concurrent other tumors or a history of tumors, or who have received anti-tumor treatment (including major surgery) within the last 4 weeks. * Allergic reactions to polatuzumab vedotin. * Other conditions where the investigator deems the patient ineligible for this study.
References
Publications (0)
Data not yet available