A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1

NCT07034508 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT2025053
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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

DLBCL - Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate (CR)

  To assess the complete response rate (CR) at the end of treatment with Treatment

  up to the end of 6 cycles of treatment (each cycle is 28 days)]

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  up to the end of 6 cycles of treatment (each cycle is 28 days)

• Duration of Response (DoR)

  up to 2 years

• Progression-free survival (PFS)

  up to 2 years

• To identify biomarkers

  up to 2 years

Study Arms (2)

4×Pola-RCHP followed by 2×Pola-R

EXPERIMENTAL

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.

Drug: Polatuzumab Vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone

6×Pola-RCHP

ACTIVE COMPARATOR

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

Drug: Polatuzumab Vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone

Interventions

Polatuzumab Vedotin DRUG

Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

4×Pola-RCHP followed by 2×Pola-R; 6×Pola-RCHP

Rituximab DRUG

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

4×Pola-RCHP followed by 2×Pola-R; 6×Pola-RCHP

Cyclophosphamide DRUG

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm

4×Pola-RCHP followed by 2×Pola-R; 6×Pola-RCHP

Doxorubicin DRUG

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

4×Pola-RCHP followed by 2×Pola-R; 6×Pola-RCHP

Prednisone DRUG

Prednisone PO will be administered as per the schedule specified in the respective arm.

4×Pola-RCHP followed by 2×Pola-R; 6×Pola-RCHP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

China Institute of Hematology and Blood Diseases Hospital

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Interventions

polatuzumab vedotin; Rituximab; Cyclophosphamide; Doxorubicin; Prednisone

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Central Study Contacts

Liang Huang

CONTACT

13971600192; huangliang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2029
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CN (1)