Clinical trial · Interventional
Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects
A Phase 2 Study Evaluating Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects
NCT03629873CI-TRIAL-00055755unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a single arm, multi-center, open study to evaluating efficacy and safety of Chi-BEAC combining with auto-HSCT to treat aggressive lymphoma Subjects
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Double-hit Lymphoma | High Grade B-Cell Lymphoma with MYC and BCL2 or BCL6 Rearrangements | ALIAS | 0.90 |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival rate
- timeFrame
- 2 years after transplantation
Secondary outcomes (4)
- measure
- Overall survival
- timeFrame
- 2 years after transplantation
- measure
- Complete remission
- timeFrame
- 3 months after transplantation
- measure
- Time of hematopoietic reconstitution
- timeFrame
- 15 days, 1 month
- measure
- Non-relapse mortality
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aggressive lymphoma subjects: diffuse large B cell lymphoma confirmed by immunohistochemistry, aaIPI≥2 or double-hit lymphoma, as first-line consolidation; diffuse large B cell lymphoma as second-line consolidation therapy; peripheral T-cell lymphoma except ALK-positive type, as first-line or second-line consolidation therapy; mantle cell lymphoma, as first-line or second-line consolidation therapy. 2. Adequate organ system function including: Creatinine clearance rate ≥ 80ml/min and creatinine \< 160μmol/L ALT/AST ≤ 2 upper limit of normal Total Bilirubin \< 2 upper limit of normal FEV1、FVC and DLCO ≥ 50% predictive value Left ventricular ejection fraction ≥ 50% No Symptomatic arrhythmia 3. Age 18-60 years, male and female 4. ECOG score 0-1 5. Number of neutrophil ≥ 1.5×10\^9/L, number of platelet ≥ 70×10\^9/L, concentration of hemoglobin ≥ 90g/L, number of CD34+ cells ≥ 2.0×10\^6/kg 6. Expected survival ≥ 12 weeks 7. Volunteered to participate in this study and signed informed consent Exclusion Criteria: 1. Have evidence of CNS lymphoma 2. Relapse after autologous hematopoietic stem cell transplantation 3. Active hepatitis B or hepatitis C virus infection 4. Severe active infection 5. HIV-infected persons 6. Liver cirrhosis or hepatic fibrosis 7. QTc \> 500ms 8. Have mental disorder or unable to sign informed consent 9. History of drug abuse and intemperance 10. Women who are pregnant or lactating or have breeding intent 11. The investigators believe that any increase in the risk of the subject or interference with the results of the trial
References
Publications (0)
Data not yet available
No reference posted for this study.