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Trial Title:
Low-dose Chidamide Maintenance Therapy After Allo-HSCT for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas
NCT ID:
NCT05991973
Condition:
T Lymphoblastic Leukemia/Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, T-Cell
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Conditions: Keywords:
chidamide
allo-HSCT
maintenance therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide
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.
Arm group label:
low-dose chidamide maintenance therapy after allo-HSCT
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. Age 14-70;
3. Stable hematopoietic reconstitution 90±10 days after receiving allogeneic
hematopoietic stem cell transplantation, no aGVHD or stable aGVHD control and stable
primary disease;
4. Complete donor chimerism after transplantation;
5. During the screening period after transplantation (within 4 weeks before Chidanilide
administration), the primary disease is remission and MRD is negative.
6. Eastern Cooperative Oncology Group (ECOG) physical condition score is 0-2 points;
7. Creatinine clearance ≥ 60 mL/min (according to the Cockcroft-Gault formula);
8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper
limit of normal range (ULN), total bilirubin ≤ 2 × ULN;
9. Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50%
10. Life expectancy >8 weeks;
11. Voluntarily sign the informed consent form, understand and comply with the
requirements of the research.
Exclusion Criteria:
1. Bone marrow recurrence or extramedullary recurrence after transplantation;
2. Hemocytopenia after transplantation: white blood cells <2000/ul, platelets
<25000/ul;
3. Active grade 3-4 acute GVHD, or active moderate-to-severe chronic GVHD that cannot
be controlled by drugs;
4. Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc.;
5. 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;
6. Other serious diseases that may limit patients to participate in this trial (such as
advanced infection, uncontrolled diabetes, renal failure);
7. 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;
8. Pregnant or lactating women;
9. Those who cannot understand and follow the research protocol or cannot sign the
informed consent form;
Gender:
All
Minimum age:
14 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanmin Zhao, PhD
Phone:
+8615858199217
Email:
yanminzhao@zju.edu.cn
Start date:
July 15, 2023
Completion date:
July 2027
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05991973
