T Cell Lymphoma
Conditions
Keywords
T cell lymphoma, Autologous Stem Cell Transplantation, Chidamide, BEAM
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 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.
Interventions
DRUGChidamide combined with BEAM
Chidamide: 30mg po D-7,D-4,D-1 and D+3 Carmustine: 300mg/m2 ivgtt D-7 Etoposide: 100mg/m2/d ivgtt q12h D-6-D-3 Cytarabine: 200mg/m2/d ivgtt q12h D-6-D-3 Melphalan: 140mg/m2 ivgtt D-2
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | Baseline up to data cut-off (up to approximately 2 years) | Progression-free survival was defined as the time from the date of ASCT until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from an cause, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Baseline up to data cut-off (up to approximately 2 years) | Overall survival was defined as the time from the date of ASCT to the date of death from any cause. |
| Complete remission rate | 3 months after the transplantation | Percentage of participants with complete response was determined on 2014 Lugano criteria. |
| The time of hematopoietic reconstruction | 2 months after the transplantation | The first day of neutrophils ≥0.5×109/L for 3 consecutive days was the time of successful implantation of granulocytes. Platelet ≥20.0×109/L for 7 consecutive days and the first day after platelet infusion was considered as the successful time of megakaryocytes implantation. |
| Transplantation-related adverse reactions | Baseline up to data cut-off (up to approximately 4 years) | Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT. |
Countries
China
Contacts
Primary ContactWeili Zhao
Backup ContactPengpeng Xu
Outcome results
None listed