ChiCGB vs BEAM in High-risk or R/R Lymphomas
- Registration Number
- NCT05466318
- Lead Sponsor
- Sichuan University
- Brief Summary
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 ChiCG...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 306
- Patients with primary refractory or recurrent diffuse large B cell lymphoma or extra-nodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.
- Relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least partial response before recruitment.
- Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
- Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) </= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 x upper limit of normal.
- Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) >/= 50% of expected corrected for hemoglobin.
- Adequate cardiac function with left ventricular ejection fraction >/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Performance status 0-1. 10. Negative Beta diffusing capacity of the lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
- Central nervous system lymphoma
- Patients relapsed after autologous stem cell transplantation
- Bone marrow was involved by lymphoma
- Patients with active hepatitis B or C(HBV DNA >/=10,000 copies/mL).
- Active infection requiring parenteral antibiotics
- HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and a normal cluster of differentiation 4 (CD4) counts
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
- Patients with a corrected QT interval(QTc) longer than 500 ms
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ChiCGB Cladribine Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. BEAM Autologous hematopoietic stem cell transplant Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation. ChiCGB Autologous hematopoietic stem cell transplant Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. ChiCGB Gemcitabine Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. ChiCGB Chidamide Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. BEAM Etoposide Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation. ChiCGB Busulfan Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation. BEAM Carmustine Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation. BEAM Cytarabine Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation. BEAM Melphalan Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) 2 years Progression free survival of this group of patients at the end of 2 year
- Secondary Outcome Measures
Name Time Method 100 day adverse events (AE) 100 days from transplant non-hematologic adverse events @ Day +100
100 day complete response (CR) rate 100 days from transplant Complete response @ Day +100
Overall survival (OS) 2 years Overall survival of this group of patients at the end of 2 year
Trial Locations
- Locations (11)
Chengdu Third People's Hospital
🇨🇳Chendu, Sichuan, China
People's Hospital of Deyang City
🇨🇳Deyang, Deyang, China
West China Hospital, Sichuan University
🇨🇳Chendu, Sichuan, China
PLA Western Theater Command General Hospital
🇨🇳Chengdu, Sichuan, China
Dazhou Central Hospital
🇨🇳Dazhou, Sichuan, China
Chengdu First People's Hospital
🇨🇳Chengdu, Sichuan, China
Central Hospital of Mianyang City
🇨🇳Mianyang, Sichuan, China
Southwest Medical University
🇨🇳Luzhou, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
🇨🇳Nanchong, Sichuan, China
Zigong First People's Hospital
🇨🇳Zigong, Sichuan, China
Guangyuan Central Hospital
🇨🇳Guangyuan, Sihcuan, China