Status:
COMPLETED
Low-dose Chidamide Maintenance Therapy After Allo-HSCT for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
The First Affiliated Hospital of Zhengzhou University
The Affiliated Hospital of Medical College, Ningbo University
Conditions:
T Lymphoblastic Leukemia/Lymphoma
Eligibility:
All Genders
14-70 years
Phase:
PHASE2
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 lymp...
Detailed Description
This is a phase ll, multi-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 an...
Eligibility Criteria
Inclusion
- 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 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
- 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;
Key Trial Info
Start Date :
July 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05991973
Start Date
July 15 2023
End Date
July 1 2025
Last Update
December 5 2025
Active Locations (1)
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1
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China, 310006