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

NCT ID: NCT05931263

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2028-02-29

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)

Conditions

Newly Diagnosed Peripheral T-cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C-BEAM

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

Group Type: EXPERIMENTAL

C-BEAM Regimen

Intervention Type: DRUG

Chidemide，carmustine, etoposide, cytarabine, and melphalan

BEAM

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

Group Type: SHAM_COMPARATOR

BEAM Regimen

Intervention Type: DRUG

carmustine, etoposide, cytarabine, and melphalan

Interventions

C-BEAM Regimen

Chidemide，carmustine, etoposide, cytarabine, and melphalan

Intervention Type: DRUG

BEAM Regimen

carmustine, etoposide, cytarabine, and melphalan

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

wei xu

Role: PRINCIPAL_INVESTIGATOR

: China, Jiangsu Hematological Department, People's Hospital of Jiangsu Province

Locations

Hematological Department, People's Hospital of Jiangsu Province

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

wei xu

Role: CONTACT

xuwei10000@hotmail.com

86-25-68302182

Facility Contacts

Wei Xu, PhD

Role: primary

xuwei10000@hotmail.com

+86-2568302182

Other Identifiers

CSIIT-T29

Identifier Type: -

Identifier Source: org_study_id