Status:
UNKNOWN
Efficacy and Safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Xinqiao Hospital of Chongqing
The First Affiliated Hospital of Anhui Medical University
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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.
Detailed Description
Peripheral T-cell lymphomas (PTCL) is a group of highly heterogeneous aggressive non-Hodgkin lymphomas originating from mature post-thymic T lymphocytes or NK/T cells. The treatment effect of patients...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 17 2025
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT04880746
Start Date
October 17 2020
End Date
October 17 2025
Last Update
May 11 2021
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China