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

Nanjing Medical University

Status and phase: Enrolling; Phase 3

Conditions: Newly Diagnosed Peripheral T-cell Lymphoma

Treatments: Drug: BEAM Regimen; Drug: C-BEAM Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT05931263

CSIIT-T29

Details and patient eligibility

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.

Full 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)

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

C-BEAM

Experimental group

Description:

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

Treatment:

Drug: C-BEAM Regimen

BEAM

Sham Comparator group

Description:

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

Treatment:

Drug: BEAM Regimen