Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05772728
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-16
First Post:
2022-12-29
Brief Title:
Chidamide Combined With Azacitidine and Mitoxantrone Liposome in the Treatment of RelapsedRefractory nTFHL
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
A Multicenter Single-arm Open Clinical Efficacy Observational Study of Cidapenem Combined With Azacitidine and Mitoxantrone Liposome CAM Regimen for RelapsedRefractory Intra-nodal Follicular Adjuvant T-cell Lymphoma nTFHL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 respectively1 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 CD279PD1 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 nTFHL1 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 ie cidapenem combined with azacitidine dual epigenetic modulation on the basis of mitoxantrone liposome in the treatment of patients with RR nTFHL using a randomized prospective multicenter phase II clinical trial which is expected to further improve ORR PFS and OS
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 ie cidapenem combined with azacitidine dual epigenetic modulation on the basis of mitoxantrone liposome in the treatment of patients with RR nTFHL using a randomized prospective multicenter phase II clinical trial which is expected to further improve ORR PFS and OS
Detailed Description:
Induction treatment period Cetapenem 20 mg orally twice a week Azacitidine 75 mgm2 subcutaneously d1-7 Mitoxantrone liposomes 20 mgm2 intravenous d6
1 treatment cycle every 21 days Maintenance treatment period cidabendiamide 20 mg orally twice weekly28 days Cycle
1 treatment cycle every 21 days Maintenance treatment period cidabendiamide 20 mg orally twice weekly28 days Cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None