Clinical trial · Interventional
A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEAM Regimen | Drug | — | UNRESOLVED |
| C-BEAM Regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- C-BEAM
- description
- Chidemide,carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation
- interventionNames
- Drug: C-BEAM Regimen
- type
- SHAM_COMPARATOR
- label
- BEAM
- description
- carmustine, etoposide, cytarabine, and melphalan plus autologous stem cell transplantation
- interventionNames
- Drug: BEAM Regimen
Primary outcomes (1)
- measure
- 2-y PFS
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available