Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell
Conditions
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 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).
Interventions
DRUGChidamide
30 mg oral twice weekly for 2 weeks
DRUGCladribine
6 mg/m2 intravenously once daily @ Day -7 \ -3
DRUGGemcitabine
2500 mg/m2 intravenously @ Day -7, -3
DRUGBusulfan
3.2 mg/kg intravenously once daily @ Day -7 \ -4
DRUGCarmustine
300 mg/m2 intravenously @ Day -8
DRUGEtoposide
200 mg/m2 intravenously once daily @ Day -7 \ -4
DRUGCytarabine
400 mg/m2 intravenously once daily @ Day -7 \ -4
DRUGMelphalan
140 mg/m2 intravenously @ Day -3
autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy
Sponsors
Sichuan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 2 years | Progression free survival of this group of patients at the end of 2 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 2 years | Overall survival of this group of patients at the end of 2 year |
| 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 |
Countries
China
Outcome results
None listed