Chidamide Plus Azacitidine for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma

Study Overview
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Brief Summary
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Untreated patients with Nodal T-follicular Helper (TFH) Cell Lymphoma will be treated with chidamide combined with azacitidine for four cycles. For patients with interim evaluation of CR, consolidation therapy with ASCT or another eight cycles with chidamide combined with azacitidine can be obtained. For patients with interim evaluation of PR, another two cycles of chidamide combined with azacitidine will be continued, followed by the second efficacy evaluation, and those who achieve CR receive consolidation therapy with ASCT or another six cycles of chidamide combined with azacitidine. Subsequently, chidamide was given as maintenance therapy for 12 months. Patients with SD or PD withdrew from this study.

Official Title
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Chidamide Plus Azacitidine Epigenetic Repression for the Treatment of Previously Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma

Conditions
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Peripheral T Cell Lymphoma, Epigenetic Repression

Intervention / Treatment
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* Drug: Chidamide
* Drug: Azacitidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma. More than 18 years of age. Proper functioning of the major organs: 1) The absolute value of neutrophils (≥1×10^9/L); 2) platelet count (≥75×10^9/L); 3) Serum total bilirubin ≤ 1.5 times ULN; 4) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN; 5) Serum creatinine (Cr) ≤2 ULN, or glomerular filtration rate ≥40ml/min; Eastern Cooperative Oncology Group (ECOG) Performance status 0-2. LVEF value measured by echocardiography ≥50%. Life expectancy > 3 months. Exclusion Criteria: Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy. Patients with central nervous system involvement by lymphoma. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases. Pregnant or breastfeeding women. Presence of human immunodeficiency virus (HIV) virus infection. Previous history of other malignant tumors, unless the disease has been cured for 5 years or more. The following cured tumors are excluded: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin and related localized non-melanoma skin cancers; Carcinoma in situ of the cervix

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interim evaluation of CR group<br>Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated with chidamide combined with azacitidine for four cycles. For patients with interim-PET evaluation of CR, consolidation therapy with ASCT or another eight cycles with chidamide combined with azacitidine can be obtained. Subsequently, cidarbenamide monotherapy was given as maintenance therapy for 12 months. Patients with interim evaluation of SD or PD withdrew from this study. | Drug: Chidamide<br>* chidamide 30mg biw, p.o, 28 days for a cycle.<br>Drug: Azacitidine<br>* 75mg/m2, continuous i.h. on day 1-7，28 days for a cycle.<br>|
| Experimental: interim evaluation of PR group<br>Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated with chidamide combined with azacitidine for four cycles. For patients with interim-PET evaluation of PR, another two cycles of chidamide combined with azacitidine will be continued, followed by the second PET-CT efficacy evaluation, and those who achieve CR receive consolidation therapy with ASCT or another six cycles of chidamide combined with azacitidine. Subsequently, cidarbenamide monotherapy was given as maintenance therapy for 12 months. Patients with second efficacy evaluation of PR or SD or PD withdrew from this study. | Drug: Chidamide<br>* chidamide 30mg biw, p.o, 28 days for a cycle.<br>Drug: Azacitidine<br>* 75mg/m2, continuous i.h. on day 1-7，28 days for a cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification by PET-CT as determined by study investigators. | 2 years post initiation of treatment | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |  | 2 years post initiation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | PFS is defined as the time from the initiation of treatment to the date of disease progression or death from any cause. | 2 years post initiation of treatment | 
| Duration of Response (DOR) | DOR is defined for participants who experience complete response after treatment and is the time from the first objective response to disease progression or death from any cause. | 2 years post initiation of treatment | 
| Overall Survival (OS) | OS is defined as the time from initiation of treatment to the date of death from any cause. | 2 years post initiation of treatment |