CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL

Официальное название

CRP Regimen (Chidamide, Rituximab and Polatuzumab Vedotin) in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL: Single-Arm, Open-Label, Multicenter Phase II Trial

Обзор

A Single-Arm, Open-Label, Multicenter Phase II Trial of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in Treating Elderly Patients with Previously Untreated Double-Positive Diffuse Large B-Cell Lymphoma

Подробное описание

This is a single-arm, open-label, multicenter Phase II trial to evaluate the feasibility, efficacy, and safety of the CRP regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in treating elderly patients with previously untreated double-expressor diffuse large B-cell lymphoma.

Вмешательства

• Препарат Chidamide
  Chidamide: patients followed a step-dose escalation regimen (10mg BIW,15mg BIW, 20mg BIW). 21 days as a treatment cycle. The maximum number of treatment cycles is six.
• Препарат Rituximab
  Day 1 of each cycle, 375 mg/m².The maximum number of treatment cycles is six.
• Препарат Polatuzumab Vedotin
  Day 1 of each cycle, 1.8 mg/kg. The maximum number of treatment cycles is six.
• Препарат Chidamide Maintenance
  For patients assessed as being in PR or CR status after completion of combination therapy, maintenance therapy with chidamide is administered for one year at a dosage of 20 mg, BIW. Drug adjustments may be made based on the patient's tolerance, with reference to the drug prescribing information.

Первичные конечные точки

• Complete Response Rate (CRR) [Срок оценки: up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days]

Вторичные конечные точки (7)

• Overall Response Rate (ORR) [Срок оценки: up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days]
• Progression-free survival (PFS) [Срок оценки: up to 2 years]
• Event free survival(EFS) [Срок оценки: up to 2 years]
• Overall Survival(OS) [Срок оценки: up to 2 years]
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: up to 2 years]
• Quality of Life Assessment - EORTC QLQ-C30 Score [Срок оценки: up to 2 years]
• Quality of Life Assessment - FACT-Lym Score [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

• Patients aged ≥70 years, or patients aged 60-69 years with an ECOG performance status score of 2-4. Both males and females are eligible.
• No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy directed at the lymphoma (excluding palliative radiotherapy for symptom relief), or surgical therapy (excluding diagnostic biopsy or surgery not targeting the lymphoma).
• Histopathological confirmation meeting all of the following conditions:

• Diagnosis of diffuse large B-cell lymphoma (DLBCL) with CD20 positivity; concurrent positive expression of C-MYC and Bcl-2 (double-expressor phenotype).
• At least one measurable lesion positive on ¹⁸F-FDG PET-CT scan according to the Lugano 2014 criteria for Hodgkin and non-Hodgkin lymphoma.
• Laboratory tests at screening must meet the following criteria, unless the investigator attributes abnormalities to lymphoma (no corrective or supportive therapy for these parameters within 2 weeks prior to assessment):

• Hematology: Hb ≥90 g/L, ANC ≥1.5 × 10⁹/L, PLT ≥90 × 10⁹/L.
• Biochemistry: Cr ≤1.5 ×ULN; TBIL ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (for patients with liver involvement: ≤5 × ULN).
• Life expectancy of at least 6 months, as judged by the investigator.
• Ability to understand and voluntarily provide written informed consent.

Критерии исключения

• History of or concurrent other active malignancies.
• Prior treatment with Chidamide and/or R-CHOP. Contraindication to any component of CHOP, including prior anthracycline therapy. History of severe hypersensitivity or anaphylaxis to humanized or murine monoclonal antibodies, or known sensitivity/allergy to murine products.
• Current diagnosis of any of the following: Follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma); Primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; Central nervous system (CNS) lymphoma (primary or secondary); Primary effusion DLBCL; Primary cutaneous DLBCL, leg type.
• History of myocardial infarction, unstable angina, or other clinically significant cardiac disease within 12 months prior to signing informed consent; or prior coronary angioplasty/stenting within 12 months.
• Clinically uncontrolled active infection (bacterial, fungal, or viral) or organ hemorrhage.
• Pregnant or lactating women.
• Participation in any other clinical trial within 6 months prior to signing informed consent.
• Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Medical University Cancer Insititute & Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07397832 · CRP-DLBCL01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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