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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
266
Semustine, 300 mg/m2,-6d; Etoposide, 100 mg/m2,-5~-2d; Cytarabine, 100mg/m2,q12h,-5~-2d; Cyclophosphamide, 1.5g/m2,-5~-2d
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
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGProgression 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.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Overall survival
Overall survival was defined as the time from the date of ASCT to the date of death from any cause.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
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.
Time frame: 3 months after the transplantation
Transplantation-related adverse reactions
Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT
Time frame: Baseline up to data cut-off (up to approximately 5 years)
Patient tolerance
Percentage of participants who can tolerate the whole treatment of ASCT
Time frame: Through the whole course of ASCT, an average of one month
Relapse rate
Percentage of participants who relapse determined on the basis of Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007.
Time frame: Baseline up to data cut-off (up to approximately 5 years)
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