Chidamide Plus R-CHOP in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes

NCT06891157 | Recruiting Phase 2

• 1 other identifier: 2024-SR-1157
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the Safety and Efficacy of CR-CHOP Treatment in Newly Diagnosed Double-Expressor DLBCL with Other Molecular Subtypes

Conditions

Chidamide; R-CHOP Chemotherapy; DLBCL - Diffuse Large B Cell Lymphoma; Double-expressor Lymphoma (DEL)

Outcome Measures

Primary Outcomes (1)

• PFS

  from date of inclusion to date of progression, relapse, or death from any cause

  2 years

Secondary Outcomes (3)

• CR rate

  up to 6 cycles (each cycle is 21 days)

• OS

  2 years

• ORR

  up to 6 cycles (each cycle is 21 days)

Study Arms (1)

CR-CHOP arm

EXPERIMENTAL

Newly Diagnosed DEL Patients Receiving Chidamide plus R-CHOP(Rituximab、Cyclophosphamide、Doxorubicin、Vincristine and Prednisone) Regimen Treatment

Drug: Chidamide plus R-CHOP

Interventions

Chidamide plus R-CHOP DRUG

Chidamide Plus R-CHOP (Rituximab、Cyclophosphamide、Doxorubicin、Vincristine and Prednisone)

CR-CHOP arm

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age;
• Diffuse large B-cell lymphoma diagnosed by pathological diagnosis according to WHO 2016 classification criteria;
• Molecular subtyping, determined through high-throughput sequencing of pathological tissue or peripheral blood, is categorized as the "Other" subtype;
• Immunohistochemistry revealed overexpression of MYC and BCL2: MYC ≥ 40%, BCL2 ≥ 50%;
• Measurable lesions identified on cross-sectional imaging through diagnostic modalities (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) are defined as the presence of at least one two-dimensional lesion with a maximum cross-sectional diameter (GTD) ≥1.5 cm, irrespective of the short-axis diameter;
• The Eastern Cooperative Oncology Group (ECOG) performance status score is ≤2；
• Adequate hepatic function is defined as: total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN; alkaline phosphatase (ALP) ≤ 5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 35 mL/min as calculated by the Cockcroft-Gault formula;
• Voluntary participation with willingness to provide the aforementioned treatment data, accompanied by a signed and dated informed consent form.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study：
• Currently enrolled in another clinical trial；
• Received prior lymphoma treatment with alternative regimens before enrollment;
• Presence of concurrent malignant tumors;
• Deemed ineligible for participation by the investigator's judgment；
• Presence of severe psychiatric or neurological disorders that may impair the ability to provide informed consent and/or affect the reporting or observation of adverse events；
• Patients unable to comply with follow-up requirements；
• Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
• Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive and HBV DNA positive), HCV positive

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wei Xu, Doctor

CONTACT

86-2568302182; xuwei10000@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 24, 2025
• Study Start: August 20, 2024
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

CN (1)