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.
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 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
44
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.
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China
Relapse-free survival(RFS)
The time from the date of treatment to the occurrence of any of the following: 1. Death from any cause 2. 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
Graft-versus-host disease (GVHD)
Acute GVHD or chronic GVHD incidence after chidamide maintenance therapy
Time frame: At Year 2
Adverse effects
Drug related adverse effects after chidamide maintenance therapy
Time frame: At Year 2
Measurable residual disease(MRD) status
Time frame: At Year 2
Changes in t lymphocyte subsets
Time frame: At Year 2
Non-relapse mortality (NRM)
Assessment of NRM at Year 2
Time frame: At Year 2
GVHD-free-relapse-free survival(GRFS)
Assessment of GRFS at Year 2
Time frame: At Year 2
Overall survival (OS)
Assessment of OS at Year 2
Time frame: At Year 2
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