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

NCT05367856 | Unknown Phase 2 DMC

• 1 other identifier: Chi-BEAM
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

T Cell Lymphoma

Keywords

T cell lymphoma; Autologous Stem Cell Transplantation; Chidamide; BEAM

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  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.

  Baseline up to data cut-off (up to approximately 2 years)

Secondary Outcomes (4)

• Overall survival

  Baseline up to data cut-off (up to approximately 2 years)

• Complete remission rate

  3 months after the transplantation

• The time of hematopoietic reconstruction

  2 months after the transplantation

• Transplantation-related adverse reactions

  Baseline up to data cut-off (up to approximately 4 years)

Study Arms (1)

Chi-BEAM

EXPERIMENTAL

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

Drug: Chidamide combined with BEAM

Interventions

Chidamide combined with BEAM 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

Chi-BEAM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≤ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weili Zhao

CONTACT

+862164370045; zwl_trial@163.com

Pengpeng Xu

CONTACT

+862164370045; pengpeng_xu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director, Hematology Department

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 10, 2022
• Study Start: May 28, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)