Efficacy and Safety of Chidamide Combined With BEAM Pretreatment Regimen in Autologous Transplantation for T-cell Lymphoma

Shanghai Jiao Tong University

Status and phase

Enrolling

Phase 2

Conditions

T Cell Lymphoma

Treatments

Drug: Chidamide combined with BEAM

Study type

Interventional

Funder types

Other

Identifiers

NCT05367856

Chi-BEAM

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

23 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.