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

Официальное название

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

Обзор

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

Подробное описание

The POLARIX study demonstrated that the Pola-R-CHP regimen (replacing vincristine in R-CHOP with Pola) significantly improves progression-free survival (PFS) and is safer than traditional R-CHOP. The FLYER study suggested that 4 cycles of R-CHOP followed by 2 additional doses of rituximab in young, low-risk DLBCL patients (IPI 0-1) are as effective as 6 cycles of R-CHOP and result in lower toxicity. Based on the efficacy of Pola-R-CHP and the potential for reducing treatment intensity in low-risk patients, this study will evaluate whether 4 cycles of Pola-R-CHP followed by 2 cycles of Pola-R are non-inferior to 6 cycles of Pola-R-CHP in treatment-naive low-risk DLBCL patients (IPI 0-1), with a potentially better safety profile.

Вмешательства

• Препарат Polatuzumab Vedotin
  Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
• Препарат Rituximab
  Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
• Препарат Cyclophosphamide
  Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm
• Препарат Doxorubicin
  Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
• Препарат Prednisone
  Prednisone PO will be administered as per the schedule specified in the respective arm.

Первичные конечные точки

• Complete response rate (CR) [Срок оценки: up to the end of 6 cycles of treatment (each cycle is 28 days)]]

Вторичные конечные точки (4)

• Overall Response Rate (ORR) [Срок оценки: up to the end of 6 cycles of treatment (each cycle is 28 days)]
• Duration of Response (DoR) [Срок оценки: up to 2 years]
• Progression-free survival (PFS) [Срок оценки: up to 2 years]
• To identify biomarkers [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China Institute of Hematology and Blood Diseases Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07034508 · IIT2025053

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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