Status:
UNKNOWN
Efficacy and Safety of Chidamide Combined With BEAM Pretreatment Regimen in Autologous Transplantation for T-cell Lymphoma
Lead Sponsor:
Ruijin Hospital
Conditions:
T Cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
T cell lymphoma (TCL) is a group of highly heterogeneous aggressive non-Hodgkin lymphomas with different pathogenesis and clinical prognosis. Despite the survival benefits of Anthracycline-based chemo...
Eligibility Criteria
Inclusion
- 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;
- 18≤ age ≤65 years old, male or female;
- ECOG score 0-1;
- 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;
- No cardiac dysfunction;
- Life expectancy over 3 months;
- The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure.
Exclusion
- Central nervous system lymphoma was excluded;
- Suffering from serious complications or severe infection;
- A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;
- Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;
- HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative;
- 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;
- Left ventricular ejection fraction ≦ 50%;
- Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;
- Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;
- Pregnant or lactating women;
- The researcher judged that the patients were not suitable for this study.
Key Trial Info
Start Date :
May 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05367856
Start Date
May 28 2022
End Date
June 1 2025
Last Update
September 29 2022
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200001