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

NCT07397832 | Recruiting Phase 2

• 1 other identifier: CRP-DLBCL01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Keywords

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CRR)

  To assess the Complete Response Rate (CR) at the end of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin).

  up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days

Secondary Outcomes (7)

• Overall Response Rate (ORR)

  up to the end of CRP Regimen treatment, no more than 6 cycles, each cycle is 21 days

• Progression-free survival (PFS)

  up to 2 years

• Event free survival(EFS)

  up to 2 years

• Overall Survival(OS)

  up to 2 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  up to 2 years

Other Outcomes (2)

• Biomarkers Associated with Treatment Response and Disease Progression

  up to 2 years

• Biomarkers Associated with Adverse Events

  up to 2 years

Study Arms (1)

Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten

EXPERIMENTAL

Each subject will be given combination therapy of Chidamide, Rituximab and Polatuzumab Vedotin.The maximum number of treatment cycles is six.

Drug: Chidamide; Drug: Rituximab; Drug: Polatuzumab Vedotin; Drug: Chidamide Maintenance

Interventions

Chidamide DRUG

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.

Also known as: HDACi

Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten

Rituximab DRUG

Day 1 of each cycle, 375 mg/m².The maximum number of treatment cycles is six.

Also known as: R

Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten

Chidamide Maintenance DRUG

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.

Also known as: HDACi Maintenance

Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten

Polatuzumab Vedotin DRUG

Day 1 of each cycle, 1.8 mg/kg. The maximum number of treatment cycles is six.

Also known as: Pola

Combination therapy with Chidamide, Rituximab and Polatuzumab VedotinCRP Regimen + Chidamide Mainten

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Insititute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Rituximab; polatuzumab vedotin; pola office

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Huilai Zhang

  Tianjin Medical University Cancer Insititute & Hospital

  STUDY DIRECTOR

Central Study Contacts

Huilai Zhang

CONTACT

+86-18622221228; huilaizhangtz@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: February 9, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)