A multicenter randomized study on the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with carmustine, etoposide, and cytarabine (modified BEAM protocol) in the pretreatment of T-cell lymphoma underwent autologous stem cell transplantation
T-cell lymphoma patients with the indication of autologous stem cell transplantation will be divided into two groups,the control group will use BEAM as conditioning regimen and the experiment group will use modified BEAM regimen(included mitoxantrone liposome,then to compare the efficacy and safety of the two conditioning regimens for patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
122
Mitoxantrone liposome 24 mg/m2,ivgtt,d-7;BCNU 300 mg/m2,ivgtt,d-6; Ara-C 200 mg/m2 q12h,ivgtt,d-5- -2; Vp16 200 mg/m2 ,ivgtt,d-5- -2;
BCNU 300 mg/m2,-7d; Vp16 200 mg/m2,-6~-3d; Ara-C 100mg/m2 q12h,-6~-3d; Mel 140mg/m2,-2d
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
relapse rate of T cell lymphoma
relapse rate at three years after transplantation
Time frame: three years after transplantation
AEs
adverse reactions included gastrointestinal,liver,renal,heart toxicities
Time frame: from beginning of the conditioning to one month after conditioning
immune reconstruction
the recovery of T, B and NK cells
Time frame: At 6 months post-transplantation
OS
overall survival
Time frame: From date of diagnosis until the end of follow-up or the date of death from any cause, whichever came first,assessed up to 36 months.
PFS
progression free survival
Time frame: From date of HSCT until the end of follow-up or the date of disease relapse from any cause, whichever came first,assessed up to 36 months.
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