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

Primary Purpose

T Lymphoblastic Leukemia/Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for T Lymphoblastic Leukemia/Lymphoma focused on measuring chidamide, allo-HSCT, maintenance therapy

Eligibility Criteria

14 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • The First Hospital of Zhejiang Medical Colleage Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

low-dose chidamide maintenance therapy after allo-HSCT

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2023
Last Updated
August 7, 2023
Sponsor
Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05991973
Brief Title
Low-dose Chidamide Maintenance Therapy After Allo-HSCT for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Lymphoblastic Leukemia/Lymphoma
Keywords
chidamide, allo-HSCT, maintenance therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low-dose chidamide maintenance therapy after allo-HSCT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relapse-free survival(RFS)
Description
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.
Time Frame
At Year 2
Secondary Outcome Measure Information:
Title
Graft-versus-host disease (GVHD)
Description
Acute GVHD or chronic GVHD incidence after chidamide maintenance therapy
Time Frame
At Year 2
Title
Adverse effects
Description
Drug related adverse effects after chidamide maintenance therapy
Time Frame
At Year 2
Title
Measurable residual disease(MRD) status
Time Frame
At Year 2
Title
Changes in t lymphocyte subsets
Time Frame
At Year 2
Title
Non-relapse mortality (NRM)
Description
Assessment of NRM at Year 2
Time Frame
At Year 2
Title
GVHD-free-relapse-free survival(GRFS)
Description
Assessment of GRFS at Year 2
Time Frame
At Year 2
Title
Overall survival (OS)
Description
Assessment of OS at Year 2
Time Frame
At Year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanmin Zhao, PhD
Phone
+8615858199217
Email
yanminzhao@zju.edu.cn
Facility Information:
Facility Name
The First Hospital of Zhejiang Medical Colleage Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanmin Zhao, PhD
Phone
+8615858199217
Email
yanminzhao@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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