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

Official title

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

Overview

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

Detailed description

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.

Interventions

• Drug 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.
• Drug Rituximab
  Day 1 of each cycle, 375 mg/m².The maximum number of treatment cycles is six.
• Drug Polatuzumab Vedotin
  Day 1 of each cycle, 1.8 mg/kg. The maximum number of treatment cycles is six.
• Drug 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.

Primary outcome measures

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

Secondary outcome measures (7)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Tianjin Medical University Cancer Insititute & Hospital — Tianjin

Identifiers

NCT: NCT07397832 · CRP-DLBCL01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗