Clinical trial · Interventional
Efficacy and Safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study
Efficacy and Safety of Cladribine Combined With BEAC ( Semustine, Etoposide, Cytarabine, Cyclophosphamide) Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study
NCT04880746CI-TRIAL-00051719unknownPhase 3ClinicalTrials.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 multi-center clinical study will evaluate the efficacy and safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma.
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 |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEAC | Drug | — | UNRESOLVED |
| Cladribine combined with BEAC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- BEAC
- description
- Patients in this arm will receive BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT
- interventionNames
- Drug: BEAC
- type
- EXPERIMENTAL
- label
- Cladribine combined with BEAC
- description
- Patients in this arm will receive Cladribine combined with BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT
- interventionNames
- Drug: Cladribine combined with BEAC
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 18-65 years old, no gender limit; * ECOG 0-2, estimated survival time ≥ 3 months; * Pathologically newly diagnosed with PTCL (except ALK+ anaplastic large cell lymphoma), with PR or CR after 6 cycles of induction chemotherapy; * Hb≥80g/L, ANC≥1.0×10\^9/L, PLT≥75×10\^9/L; TBIL≤1.5×ULN, ALT/AST≤2.0× ULN, Cr ≤1.5×ULN in the 14 days before enrollment * Have not received hematopoietic stem cell transplantation and other treatments within 4 weeks before enrollment; * The number of hematopoietic stem cells requires MNC ≥3×10\^8/kg and/or CD34 cells ≥2×10\^6/kg; * Informed consented Exclusion Criteria: * Accompanied by severe cardiac insufficiency, cardiac ejection fraction \<60%; or severe arrhythmia, intolerance of pretreatment; * Accompanied by severe pulmonary insufficiency (obstructive and or restrictive ventilatory disorders), intolerance of pretreatment; * Accompanied by severe liver function impairment, liver function indexes (ALT, TBIL) are more than 3 times higher than the upper limit of normal, intolerance of pretreatment; * Accompanied by severe renal insufficiency, the renal function index (Cr) is more than 2 times the upper limit of normal; or the 24-hour urine creatinine clearance rate Ccr is less than 50ml/min, intolerance of pretreatment; * Severe active infection before transplantation, intolerance of pretreatment; * Accompanied by brain dysfunction or severe mental illness, unable to understand or follow the research plan; * Pregnant or lactation; * Accompanied by other malignant tumors in need of treatment; * Patients who cannot guarantee the completion of the necessary treatment plan and follow-up observation.
References
Publications (0)
Data not yet available
No reference posted for this study.