Efficacy and Safety of Chidamide Combined With BEAM Pretreatment Regimen in Autologous Transplantation for T-cell Lymphoma: a Single-center, Single-arm Clinical Study

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This single-center, single-arm clinical study will evaluate the efficacy and safety of Chidamide combined with BEAM Pretreatment Regimen in ASCT treatment of TCL patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital

Criteria

Inclusion Criteria:

1. According to world Health Organization (WHO) classification of disease, T cell lymphoma (excepted IPI 0-1 point ALK+ anaplastic cell lymphoma) was confirmed by histology, CR or PR after first-line treatment;

2. 18≤ age ≤65 years old, male or female;

3. ECOG score 0-1;

4. No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :

• White blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×109/L, Hemoglobin ≥90g/L, platelet ≥75×109/L;

• Total bilirubin ≤1.5× upper normal value (ULN);

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× upper normal value (ULN);

• Creatinine clearance was 44-133 mmol/L;

5. No cardiac dysfunction;

6. Life expectancy over 3 months;

7. The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure.

Exclusion Criteria:

1. Central nervous system lymphoma was excluded;

2. Suffering from serious complications or severe infection;

3. A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;

4. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;

5. HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative;

6. Laboratory test value during screening;

① Neutrophils <1.5×109/L; Platelet <75×109/L;

② Bilirubin was 1.5 times higher than the normal upper limit, transaminase was 2.5 times higher than the normal upper limit;

③ The creatinine level is higher than 1.5 times the upper limit of normal value;

7. Left ventricular ejection fraction ≦ 50%;

8. Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;

9. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;

10. Pregnant or lactating women;

11. The researcher judged that the patients were not suitable for this study.