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

Peripheral T-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04880746
• Other study ID #: ASCT-001
• Status: Recruiting
• Phase: Phase 3
• Start date: October 17, 2020
• Est. completion date: October 17, 2025

Study information

• Verified date: May 2021
• Source: Ruijin Hospital
• Contact: Weili Zhao
• Phone: +862164370045
• Email: zwl_trial[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: October 17, 2025
• Est. primary completion date: October 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

Drug:
• BEAC
Semustine, 300 mg/m2,-6d; Etoposide, 100 mg/m2,-5~-2d; Cytarabine, 100mg/m2,q12h,-5~-2d; Cyclophosphamide, 1.5g/m2,-5~-2d
• Cladribine combined with BEAC
Cladribine, 6mg/m2,-5~-2d, two hours before Cytarabine Semustine, 300 mg/m2,-6d; Etoposide, 100 mg/m2,-5~-2d; Cytarabine, 100mg/m2,q12h,-5~-2d; Cyclophosphamide, 1.5g/m2,-5~-2d

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (11)

Lead Sponsor

Collaborator

Ruijin Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Progression-free survival was defined as the time from the date of ASCT until the date of the first documented day of disease progression or relapse, using Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007, or death from any cause, whichever occurred first.	Baseline up to data cut-off (up to approximately 2 years)
Secondary	Overall survival	Overall survival was defined as the time from the date of ASCT to the date of death from any cause.	Baseline up to data cut-off (up to approximately 2 years)
Secondary	Overall remission rate	Percentage of participants with overall response was determined on the basis of Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007.	3 months after the transplantation
Secondary	Transplantation-related adverse reactions	Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT	Baseline up to data cut-off (up to approximately 5 years)
Secondary	Patient tolerance	Percentage of participants who can tolerate the whole treatment of ASCT	Through the whole course of ASCT, an average of one month
Secondary	Relapse rate	Percentage of participants who relapse determined on the basis of Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007.	Baseline up to data cut-off (up to approximately 5 years)