NCT05931263 A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL
| NCT ID | NCT05931263 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Newly Diagnosed Peripheral T-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 104 participants in total. It began in 2023-06-01 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
wei xu
PRINCIPAL INVESTIGATOR
: China, Jiangsu Hematological Department, People's Hospital of Jiangsu Province
Frequently Asked Questions
Who can join the NCT05931263 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Newly Diagnosed Peripheral T-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05931263 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 104 participants.
Is NCT05931263 currently recruiting?
Yes, NCT05931263 is actively recruiting participants. Contact the research team at xuwei10000@hotmail.com for enrollment information.
Where is the NCT05931263 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05931263 clinical trial?
NCT05931263 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is wei xu at : China, Jiangsu Hematological Department, People's Hospital of Jiangsu Province. The trial plans to enroll 104 participants.