Back to resultsEfficacy and Safety of Chidamide Combined With BEAM Pretreatment Regimen in Autologous Transplantation for T-cell Lymphoma
Primary Purpose
T Cell Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide combined with BEAM
Sponsored by
About this trial
This is an interventional treatment trial for T Cell Lymphoma focused on measuring T cell lymphoma, Autologous Stem Cell Transplantation, Chidamide, BEAM
Eligibility Criteria
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.
Sites / Locations
- Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chi-BEAM
Arm Description
Patients in this arm will receive Chidamide Combined With BEAM(Carmustine, Etoposide Cytarabine and Melphalan) as Pretreatment Regimen of ASCT.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall survival
Overall survival was defined as the time from the date of ASCT to the date of death from any cause.
Complete remission rate
Percentage of participants with complete response was determined on 2014 Lugano criteria.
The time of hematopoietic reconstruction
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
Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05367856
Brief Title
Efficacy and Safety of Chidamide Combined With BEAM Pretreatment Regimen in Autologous Transplantation for T-cell Lymphoma
Official Title
Efficacy and Safety of Chidamide Combined With BEAM(Carmustine, Etoposide Cytarabine and Melphalan) Pretreatment in Autologous Transplantation for T-cell Lymphoma: a Single-center, Single-arm Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Cell Lymphoma
Keywords
T cell lymphoma, Autologous Stem Cell Transplantation, Chidamide, BEAM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chi-BEAM
Arm Type
Experimental
Arm Description
Patients in this arm will receive Chidamide Combined With BEAM(Carmustine, Etoposide Cytarabine and Melphalan) as Pretreatment Regimen of ASCT.
Intervention Type
Drug
Intervention Name(s)
Chidamide combined with BEAM
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression free survival
Description
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.
Time Frame
Baseline up to data cut-off (up to approximately 2 years)
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival was defined as the time from the date of ASCT to the date of death from any cause.
Time Frame
Baseline up to data cut-off (up to approximately 2 years)
Title
Complete remission rate
Description
Percentage of participants with complete response was determined on 2014 Lugano criteria.
Time Frame
3 months after the transplantation
Title
The time of hematopoietic reconstruction
Description
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.
Time Frame
2 months after the transplantation
Title
Transplantation-related adverse reactions
Description
Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao
Phone
+862164370045
Email
zwl_trial@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pengpeng Xu
Phone
+862164370045
Email
pengpeng_xu@126.com
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao
Phone
+862164370045
Email
zwl_trial@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Chidamide Combined With BEAM Pretreatment Regimen in Autologous Transplantation for T-cell Lymphoma
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