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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Newly Diagnosed Peripheral T-cell Lymphoma

Intervention / Treatment
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* Drug: C-BEAM Regimen
* Drug: BEAM Regimen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-BEAM<br>Chidemide，carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation | Drug: C-BEAM Regimen<br>* Chidemide，carmustine, etoposide, cytarabine, and melphalan<br>|
| Sham Comparator: BEAM<br>carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation | Drug: BEAM Regimen<br>* carmustine, etoposide, cytarabine, and melphalan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-y PFS | 2-year PFS | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year OS |  | 2 years | 
| CR rate at 3 months post-transplant evalutation |  | 2 years | 
| hematopoietic reconstitution time |  | 2 years | 
| Non-recurrent mortality |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTCL, Chidemide