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A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL

Primary Purpose

Newly Diagnosed Peripheral T-cell Lymphoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
C-BEAM Regimen
BEAM Regimen
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newly Diagnosed Peripheral T-cell Lymphoma focused on measuring PTCL, Chidemide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pathologically diagnosed patients with newly treated PTCL (including NT/ K-cell lymphoma), except for ALK (+), have CR or PR after first-line treatment; Renal function needs to be satisfied: creatinine clearance ≥80ml/min, creatinine less than 160μmol/L; Liver function requirements: ALT and AST≤2 times the upper limit of normal; Total bilirubin ≤2 times the upper limit of normal; Lung function should meet: FEV1, FVC, DLCO≥50% predictive value; Cardiac function must be satisfied: left ventricular ejection fraction ≥50%, asymptomatic arrhythmia. Age between 18 and 65 years old, male and female; ECOG physical strength score 0-1; Neutrophil absolute value ≥1.5×109/L, platelets ≥ 70×109/L, hemoglobin ≥ 90g/L; Number of CD34+ cells ≥ 2.0×106/kg body weight; Expected survival time ≥3 months; Voluntarily sign written informed consent. Exclusion Criteria: Lymphoma involving the central nervous system Active hepatitis B or C virus infection; Active infection; HIV infected persons; Evidence of cirrhosis or liver fibrosis; Ecg showed QTc > 500ms; Persons with mental disabilities/unable to obtain informed consent; Patients with drug or chronic alcohol abuse that may affect the evaluation of study results; Pregnant and lactating women and women of childbearing age who do not want to take contraceptive measures; The researcher determines that it is not suitable to participate in this study

Sites / Locations

  • Hematological Department, People's Hospital of Jiangsu ProvinceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

C-BEAM

BEAM

Arm Description

Chidemide,carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation

carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation

Outcomes

Primary Outcome Measures

2-y PFS
2-year PFS

Secondary Outcome Measures

2-year OS
CR rate at 3 months post-transplant evalutation
hematopoietic reconstitution time
Non-recurrent mortality

Full Information

First Posted
June 27, 2023
Last Updated
June 27, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05931263
Brief Title
A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL
Official Title
A Randomized Controlled Clinical Trial Comparing Chidamide,Carmustine,Etoposide,Cytarabine and Melphalan With BEAM Regimen Combined With Autologus Hematopoietic Stem Cell Transplantation for the Treatment of Newly Diagnosed PTCL
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of this clinical trial is to compare Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL. The main question it aims to answer are: •Whether Chi-BEAM improves patient survival compared to BEAM group Participants will be given BEAM or Chi-BEAM before ASCT. Researchers will compare the efficacy and safety of the two groups.
Detailed Description
This is a prospective, multicenter, randomized controlled, open trial. The primary endpoint was 2-year PFS The secondary endpoint was: 2-year overall survival (OS). CR rate at 3 months post-transplant evaluation Hematopoietic reconstitution time Non-recurrent mortality (NRM)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly Diagnosed Peripheral T-cell Lymphoma
Keywords
PTCL, Chidemide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C-BEAM
Arm Type
Experimental
Arm Description
Chidemide,carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation
Arm Title
BEAM
Arm Type
Sham Comparator
Arm Description
carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation
Intervention Type
Drug
Intervention Name(s)
C-BEAM Regimen
Intervention Description
Chidemide,carmustine, etoposide, cytarabine, and melphalan
Intervention Type
Drug
Intervention Name(s)
BEAM Regimen
Intervention Description
carmustine, etoposide, cytarabine, and melphalan
Primary Outcome Measure Information:
Title
2-y PFS
Description
2-year PFS
Time Frame
2 years
Secondary Outcome Measure Information:
Title
2-year OS
Time Frame
2 years
Title
CR rate at 3 months post-transplant evalutation
Time Frame
2 years
Title
hematopoietic reconstitution time
Time Frame
2 years
Title
Non-recurrent mortality
Time Frame
2 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: Pathologically diagnosed patients with newly treated PTCL (including NT/ K-cell lymphoma), except for ALK (+), have CR or PR after first-line treatment; Renal function needs to be satisfied: creatinine clearance ≥80ml/min, creatinine less than 160μmol/L; Liver function requirements: ALT and AST≤2 times the upper limit of normal; Total bilirubin ≤2 times the upper limit of normal; Lung function should meet: FEV1, FVC, DLCO≥50% predictive value; Cardiac function must be satisfied: left ventricular ejection fraction ≥50%, asymptomatic arrhythmia. Age between 18 and 65 years old, male and female; ECOG physical strength score 0-1; Neutrophil absolute value ≥1.5×109/L, platelets ≥ 70×109/L, hemoglobin ≥ 90g/L; Number of CD34+ cells ≥ 2.0×106/kg body weight; Expected survival time ≥3 months; Voluntarily sign written informed consent. Exclusion Criteria: Lymphoma involving the central nervous system Active hepatitis B or C virus infection; Active infection; HIV infected persons; Evidence of cirrhosis or liver fibrosis; Ecg showed QTc > 500ms; Persons with mental disabilities/unable to obtain informed consent; Patients with drug or chronic alcohol abuse that may affect the evaluation of study results; Pregnant and lactating women and women of childbearing age who do not want to take contraceptive measures; The researcher determines that it is not suitable to participate in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wei xu
Phone
86-25-68302182
Email
xuwei10000@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wei xu
Organizational Affiliation
: China, Jiangsu Hematological Department, People's Hospital of Jiangsu Province
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematological Department, People's Hospital of Jiangsu Province
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Xu, PhD
Phone
+86-2568302182
Email
xuwei10000@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL

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