High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
306
30 mg oral twice weekly for 2 weeks
6 mg/m2 intravenously once daily @ Day -7 \~ -3
2500 mg/m2 intravenously @ Day -7, -3
3.2 mg/kg intravenously once daily @ Day -7 \~ -4
300 mg/m2 intravenously @ Day -8
200 mg/m2 intravenously once daily @ Day -7 \~ -4
400 mg/m2 intravenously once daily @ Day -7 \~ -4
140 mg/m2 intravenously @ Day -3
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy
People's Hospital of Deyang City
Deyang, Deyang, China
NOT_YET_RECRUITINGChengdu Third People's Hospital
Chengdu, Sichuan, China
NOT_YET_RECRUITINGWest China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGChengdu First People's Hospital
Chengdu, Sichuan, China
RECRUITINGPLA Western Theater Command General Hospital
Chengdu, Sichuan, China
RECRUITINGDazhou Central Hospital
Dazhou, Sichuan, China
NOT_YET_RECRUITINGSouthwest Medical University
Luzhou, Sichuan, China
RECRUITINGCentral Hospital of Mianyang City
Mianyang, Sichuan, China
RECRUITINGAffiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
NOT_YET_RECRUITINGZigong First People's Hospital
Zigong, Sichuan, China
RECRUITING...and 1 more locations
Progression free survival (PFS)
Progression free survival of this group of patients at the end of 2 year
Time frame: 2 years
Overall survival (OS)
Overall survival of this group of patients at the end of 2 year
Time frame: 2 years
100 day adverse events (AE)
non-hematologic adverse events @ Day +100
Time frame: 100 days from transplant
100 day complete response (CR) rate
Complete response @ Day +100
Time frame: 100 days from transplant
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