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

NCT05991973 | Completed Phase 2

• 1 other identifier: IIT20230004C-R2
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

T Lymphoblastic Leukemia/Lymphoma

Keywords

chidamide; allo-HSCT; maintenance therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  At Year 2

Secondary Outcomes (7)

• Graft-versus-host disease (GVHD)

  At Year 2

• Adverse effects

  At Year 2

• Measurable residual disease(MRD) status

  At Year 2

• Changes in t lymphocyte subsets

  At Year 2

• Non-relapse mortality (NRM)

  At Year 2

Study Arms (1)

low-dose chidamide maintenance therapy after allo-HSCT

EXPERIMENTAL

Drug: Chidamide

Interventions

Chidamide DRUG

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.

low-dose chidamide maintenance therapy after allo-HSCT

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhejiang University: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The Affiliated Hospital of Medical College, Ningbo University: collaborator

Study Sites (1)

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Lymphoma

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The President of The First Affiliated Hospital, College of Medicine, Zhejiang University

Study Record Dates

• First Submitted: July 23, 2023
• First Posted: August 15, 2023
• Study Start: July 15, 2023
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 5, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)