Actively Recruiting
A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-07-05
104
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically diagnosed newly treated PTCL patients (including NT/K-cell lymphoma), excluding ALK (+), with CR or PR after first-line treatment
- Kidney function with creatinine clearance 80 ml/min and creatinine less than 160 bcmol/L
- Liver function: ALT and AST 2 times upper limit of normal; total bilirubin 2 times upper limit of normal
- Lung function: FEV1, FVC, DLCO 50% predicted value
- Cardiac function: left ventricular ejection fraction 50%, asymptomatic arrhythmia
- Age between 18 and 65 years, both male and female
- ECOG physical strength score of 0-1
- Neutrophil count 1.5�d7109/L, platelets 70�d7109/L, hemoglobin 90 g/L
- Number of CD34+ cells 2.0�d7106/kg body weight
- Expected survival time of at least 3 months
- Voluntary written informed consent
You will not qualify if you...
- Lymphoma involving the central nervous system
- Active hepatitis B or C virus infection
- Active infection
- HIV infection
- Evidence of cirrhosis or liver fibrosis
- ECG showing QTc > 500 ms
- Mental disabilities or inability to provide informed consent
- Drug or chronic alcohol abuse affecting study evaluation
- Pregnant or lactating women and women of childbearing potential not using contraception
- Investigator determination of unsuitability for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
W
wei xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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