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

NCT ID: NCT05367856

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-28
• Study Completion Date: 2025-06-01

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.

Conditions

T Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chi-BEAM

Patients in this arm will receive Chidamide Combined With BEAM(Carmustine, Etoposide Cytarabine and Melphalan) as Pretreatment Regimen of ASCT.

Group Type: EXPERIMENTAL

Chidamide combined with BEAM

Intervention Type: DRUG

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

Interventions

Chidamide 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

First Deputy Director, Hematology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weili Zhao

Role: CONTACT

zwl_trial@163.com

+862164370045

Pengpeng Xu

Role: CONTACT

pengpeng_xu@126.com

+862164370045

Facility Contacts

Weili Zhao

Role: primary

zwl_trial@163.com

+862164370045

Other Identifiers

Chi-BEAM

Identifier Type: -

Identifier Source: org_study_id