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Trial Title:
A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL
NCT ID:
NCT05931263
Condition:
Newly Diagnosed Peripheral T-cell Lymphoma
Conditions: Official terms:
Lymphoma, T-Cell, Peripheral
Cytarabine
Carmustine
Melphalan
Etoposide
Conditions: Keywords:
PTCL
Chidemide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
C-BEAM Regimen
Description:
Chidemide，carmustine, etoposide, cytarabine, and melphalan
Arm group label:
C-BEAM
Intervention type:
Drug
Intervention name:
BEAM Regimen
Description:
carmustine, etoposide, cytarabine, and melphalan
Arm group label:
BEAM
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)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathologically diagnosed patients with newly treated PTCL (including NT/ K-cell
lymphoma), except for ALK (+), have CR or PR after first-line treatment;
2. 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.
3. Age between 18 and 65 years old, male and female;
4. ECOG physical strength score 0-1;
5. Neutrophil absolute value ≥1.5×109/L, platelets ≥ 70×109/L, hemoglobin ≥ 90g/L;
Number of CD34+ cells ≥ 2.0×106/kg body weight;
6. Expected survival time ≥3 months;
7. Voluntarily sign written informed consent.
Exclusion Criteria:
1. Lymphoma involving the central nervous system
2. Active hepatitis B or C virus infection;
3. Active infection;
4. HIV infected persons;
5. Evidence of cirrhosis or liver fibrosis;
6. Ecg showed QTc > 500ms;
7. Persons with mental disabilities/unable to obtain informed consent;
8. Patients with drug or chronic alcohol abuse that may affect the evaluation of study
results;
9. Pregnant and lactating women and women of childbearing age who do not want to take
contraceptive measures;
10. The researcher determines that it is not suitable to participate in this study
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hematological Department, People's Hospital of Jiangsu Province
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Xu, PhD
Phone:
+86-2568302182
Email:
xuwei10000@hotmail.com
Start date:
June 1, 2023
Completion date:
February 2028
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05931263
