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Chidamide Combined With Azacitidine and Mitoxantrone Liposome in the Treatment of Relapsed/Refractory (nTFHL)

NCT05772728 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-03-16

No results posted yet for this study

Summary

Intranodal follicular adjuvant T-cell lymphoma (nTFHL) is a type of peripheral T-cell lymphoma (PTCL) that is a new subtype in WHO 2022, which includes 3 categories corresponding to previous angioimmunoblast T-cell lymphoma (AITL), follicular T-cell lymphoma, and PTCL with TFH phenotype, named nTFHL-angioblast type ( nTFHL-AI), nTFHL-follicular (nTFHL-F), and nTFHL-non-specific (nTFH-NOS), respectively.1 nTFHL-AI has a relatively high incidence in PTCL, accounting for about 25-30% of cases, with an aggressive clinical presentation, often with multisystem involvement and with immune system abnormalities. nTFHL shares common immunophenotypic features, namely TFH cell phenotype: CD279/PD1, CD10, BCL6, CXCL13, ICOS, SAP, and CCR5, and at least 2 of the stated immune markers combined with CD4 positivity are required for the diagnosis of nTFHL.1, TFH cell and nTFHL cell also share similar reproducible genetic abnormalities, such as RHOA G17V, DNMT3A, IDH2, TET2, often involving epigenetic genetic abnormalities 2, especially abnormalities of DNMT3A, IDH2, and TET2 are more frequent in myeloid disorders.

Basic studies have shown that cidabenamide and anthracyclines have synergistic effects to promote apoptosis in PTCL cells; and the adverse events of the two do not completely overlap, suggesting that a mitoxantrone liposome-based regimen combined with cidabenamide for PTCL may have a better clinical benefit.

Based on the above findings, the investigators propose to further investigate the efficacy and safety of cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimen, i.e., cidapenem combined with azacitidine dual epigenetic modulation on the basis of mitoxantrone liposome, in the treatment of patients with R/R nTFHL using a randomized, prospective, multicenter phase II clinical trial, which is expected to further improve ORR, PFS and OS.

Conditions

  • T Cell Lymphoma

Interventions

DRUG

Cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimen

CAM regimen (every 21 days as a treatment cycle). Cetapenem 20 mg orally twice weekly Azacitidine 75 mg/m2 subcutaneously d1-7 Mitoxantrone liposomes 20 mg/m2 intravenous d6

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2023-12-31
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05772728 on ClinicalTrials.gov