efficacy and safety of chidamide combined with beam pretreatment regimen in autologous transplantation for t-cell lymphoma

Conditions: T Cell Lymphoma

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.

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 chemotherapy bridging autologous stem cell transplantation (asct), 40% to 50% of tcl patients fail to respond to treatment and relapse or die within a short period of time. in 2021, a multicenter, single-arm, open phase ii trial of chidamide combined with beac as a pretreatment regimen for asct of high-risk and relapsed/refractory lymphoma was presented at the ash meeting (nct03629873). the results confirmed that chidamide has a good prospect in asct. chi-beac can increase 2y-pfs from 55% to 93.3% and 2y-os from 58% to 94% in tcl patients after asct compared with the historical control group, with good tolerance.in order to provide a new program for improving survival rate, 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.

Eligibility 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.

Keywords: t cell lymphoma autologous stem cell transplantation chidamide beam