Low-dose Chidamide Maintenance Therapy After Allo-HSCT for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas
A Phase ll, Multi-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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Yanmin Zhao, PhD
- Phone Number: +8615858199217
- Email: yanminzhao@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310006
- The First Hospital of Zhejiang Medical Colleage Zhejiang University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: low-dose chidamide maintenance therapy after allo-HSCT
|
Chidamide was initiated between days +30 and +100 post-transplant at 10 mg twice weekly (BIW), continued for up to 2 years (24 courses, 4 weeks as a course) or until relapse, intolerable toxicity, or withdrawal.
The dose could be escalated to a maximum of 20 mg BIW if MRD became positive during treatment.
Donor lymphocyte infusion (DLI) was permitted in cases of MRD positivity.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relapse-free survival(RFS)
Time Frame: At Year 2
|
The time from the date of treatment to the occurrence of any 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
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Graft-versus-host disease (GVHD)
Time Frame: At Year 2
|
Acute GVHD or chronic GVHD incidence after chidamide maintenance therapy
|
At Year 2
|
|
Adverse effects
Time Frame: At Year 2
|
Drug related adverse effects after chidamide maintenance therapy
|
At Year 2
|
|
Measurable residual disease(MRD) status
Time Frame: At Year 2
|
At Year 2
|
|
|
Changes in t lymphocyte subsets
Time Frame: At Year 2
|
At Year 2
|
|
|
Non-relapse mortality (NRM)
Time Frame: At Year 2
|
Assessment of NRM at Year 2
|
At Year 2
|
|
GVHD-free-relapse-free survival(GRFS)
Time Frame: At Year 2
|
Assessment of GRFS at Year 2
|
At Year 2
|
|
Overall survival (OS)
Time Frame: At Year 2
|
Assessment of OS at Year 2
|
At Year 2
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IIT20230004C-R2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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