Low-dose chidamide therapy after stem cell transplant for T-cell leukemia or lymphomas

A Phase ll,Single-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

This study is testing if a low-dose treatment called chidamide can help people with high-risk T-cell leukemia or lymphomas stay healthy after a stem cell transplant.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 14 Years to 90 Years
• Sex: All
• Sponsor: Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05991973 on ClinicalTrials.gov

What this trial studies

This phase II clinical study evaluates the safety and effectiveness of low-dose chidamide maintenance therapy following allogeneic hematopoietic stem cell transplantation in patients with high-risk T-cell acute lymphoblastic leukemia or T-cell lymphomas. The study is single-center and single-arm, enrolling 44 patients to assess outcomes such as relapse-free survival and overall survival. Participants must demonstrate stable hematopoietic reconstitution and be in remission with negative minimal residual disease (MRD) prior to treatment.

Who should consider this trial

Good fit: Ideal candidates are patients aged 14-70 with high-risk T-cell acute lymphoblastic leukemia or T-cell lymphomas who have undergone allogeneic stem cell transplantation and are in remission.

Not a fit: Patients with active disease, severe acute graft-versus-host disease (aGVHD), or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly reduce the risk of relapse in patients with high-risk T-cell leukemia or lymphomas after transplantation.

How similar studies have performed: Other studies have shown promising results with maintenance therapies in similar contexts, suggesting potential for success with this approach.

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;

Where this trial is running

Hangzhou, Zhejiang

• The First Hospital of Zhejiang Medical Colleage Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Yanmin Zhao, PhD

Conditions: T Lymphoblastic Leukemia/Lymphoma, chidamide, allo-HSCT, maintenance therapy