Efficacy and Safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study

• Status: Recruiting
• Trial end date: 2025-10-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Collaborators: Fujian Medical University Union Hospital; Harbin Hematology and Oncology Institute; Huashan Hospital; Qilu Hospital of Shandong University; RenJi Hospital; Shanxi Province Cancer Hospital; The Affiliated Zhongshan Hospital of Dalian University; The First Affiliated Hospital of Anhui Medical University; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Xinqiao Hospital of Chongqing
• Treatments: Cladribine

Criteria

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.