Low-dose Chidamide Maintenance Therapy After Allo-HSCT for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas

Study Overview
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Brief Summary
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Clinical Study on the Safety and Effectiveness of low-dose chidamide maintenance therapy after allogeneic hematopoietic stem cell transplantation for T-cell acute lymphoblastic leukemia or T-cell lymphomas.

Detailed Description
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This is a phase ll, single-center, single-arm clinical study.This study is indicated for high-risk of T-cell acute lymphoblastic leukemia or T-cell lymphomas patients. It aims to evaluate the safety and effectiveness of low-dose chidamide maintenance therapy after allogeneic hematopoietic stem cell transplantation for T-cell acute lymphoblastic leukemia or T-cell lymphomas to prevent relapse. 44 patients will be enrolled. The clinical end points include relapse-free survival, acute or chronic GVHD, non-relapse mortality, and overall survival, etc.

Official Title
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A Phase ll,Single-center,Single-arm Clinical Study of Low-dose Chidamide Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas

Conditions
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T Lymphoblastic Leukemia/Lymphoma

Intervention / Treatment
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* Drug: Chidamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: T-cell acute lymphoblastic leukemia or T-cell lymphomas (mainly including peripheral T-cell lymphoma, NK/T-cell lymphoma, T-lymphoblastic lymphoma, etc.) must be diagnosed before enrollment. The diagnostic criteria refer to the 2016 WHO classification. Patients is in high-risk group or standard-risk group with MRD-positive patients after transplantation. Age 14-70; Stable hematopoietic reconstitution 90±10 days after receiving allogeneic hematopoietic stem cell transplantation, no aGVHD or stable aGVHD control and stable primary disease; Complete donor chimerism after transplantation; During the screening period after transplantation (within 4 weeks before Chidanilide administration), the primary disease is remission and MRD is negative. Eastern Cooperative Oncology Group (ECOG) physical condition score is 0-2 points; Creatinine clearance ≥ 60 mL/min (according to the Cockcroft-Gault formula); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal range (ULN), total bilirubin ≤ 2 × ULN; Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50% Life expectancy >8 weeks; Voluntarily sign the informed consent form, understand and comply with the requirements of the research. Exclusion Criteria: Bone marrow recurrence or extramedullary recurrence after transplantation; Hemocytopenia after transplantation: white blood cells <2000/ul, platelets <25000/ul; Active grade 3-4 acute GVHD, or active moderate-to-severe chronic GVHD that cannot be controlled by drugs; Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc.; Currently suffering from clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, prolonged QTc interval of electrocardiogram, uncontrolled uncontrolled hypertension, congestive heart failure, any New York Heart Association (NYHA) functional class 3 or 4 cardiac disease, or a history of myocardial infarction within 6 months before screening; Other serious diseases that may limit patients to participate in this trial (such as advanced infection, uncontrolled diabetes, renal failure); Known human immunodeficiency virus (HIV) infection, or hepatitis B virus that cannot be controlled by drugs (HBV-DNA positive, and HBV DNA test value above the upper limit of normal value) or hepatitis C virus (anti-HCV positive, and HCV viral titer detection value above the upper limit of normal value) Chronic Infect; Pregnant or lactating women; Those who cannot understand and follow the research protocol or cannot sign the informed consent form;

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 90 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-dose chidamide maintenance therapy after allo-HSCT<br> | Drug: Chidamide<br>* In the time window of 30-180 days after transplantation: oral chidamide 10mg twice a week with a total of 96 courses(4 weeks as a course). If the MRD turns positive during treatment, the dose can be increased to a maximum of 20 mg twice a week, and donor lymphocyte infusion (DLI) is also permitted in the case of MRD positivity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival(RFS) | The time from the date of treatment to the occurrence of any of the following: Death from any cause Disease recurrence, defined as one of the following: Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions. | At Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft-versus-host disease (GVHD) | Acute GVHD or chronic GVHD incidence after chidamide maintenance therapy | At Year 2 | 
| Adverse effects | Drug related adverse effects after chidamide maintenance therapy | At Year 2 | 
| Measurable residual disease(MRD) status |  | At Year 2 | 
| Changes in t lymphocyte subsets |  | At Year 2 | 
| Non-relapse mortality (NRM) | Assessment of NRM at Year 2 | At Year 2 | 
| GVHD-free-relapse-free survival(GRFS) | Assessment of GRFS at Year 2 | At Year 2 | 
| Overall survival (OS) | Assessment of OS at Year 2 | At Year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chidamide, allo-HSCT, maintenance therapy