Clinical trial NCT04880746: Efficacy and Safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Peripheral T-cell Lymphoma
Keywords: Peripheral T-cell lymphoma
Autologous stem cell transplantation
Cladribine
BEAC
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Xinqiao Hospital of Chongqing
name: The First Affiliated Hospital of Anhui Medical University
name: Harbin Hematology and Oncology Institute
name: The Affiliated Zhongshan Hospital of Dalian University
name: Qilu Hospital of Shandong University
name: Fujian Medical University Union Hospital
name: Shanxi Province Cancer Hospital
name: RenJi Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Huashan Hospital
First posted: 2021-05-11
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 receiving autologous hematopoietic stem cell transplantation (ASCT) is better than traditional chemotherapy, but the recurrence after transplantation is still as high as 50%. It is an urgent clinical problem to reduce the recurrence after PTCL transplantation. Cladribine can kill quiescent tumor cells, which is the main reason of tumor recurrence. Since 2018, our center has used cladribine combined with BEAC pretreatment regimen to treat 20 patients with PTCL. The PFS reached 68% at 2 years, which is about 15% higher than the previous classic BEAC regimen. This multi-center clinical study will further evaluate the efficacy and safety of Cladribine combined with BEAC pretreatment regimen in the Treatment of Peripheral T-cell Lymphoma.

Eligibility 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.

Primary outcomes:
measure: Progression free survival
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
Secondary outcomes:
measure: Overall survival
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
measure: Overall remission rate
timeFrame: 3 months after the transplantation
measure: Transplantation-related adverse reactions
timeFrame: Baseline up to data cut-off (up to approximately 5 years)
measure: Patient tolerance
timeFrame: Through the whole course of ASCT, an average of one month
measure: Relapse rate
timeFrame: Baseline up to data cut-off (up to approximately 5 years)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Weili Zhao
role: STUDY_CHAIR
References: