Lymphoma
Conditions
Keywords
NK/T cell lymphoma, Response Rate, TTP, OS, Toxicities
Brief summary
The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.
Detailed description
Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP.The investigators did this trial to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in the patients with NK/T cell lymphoma.
Interventions
DRUGIFO, VP-16, DDP, DXM
DXM 40 mg d1-4; IFO 1200mg/m2 d1-4; Mesna 400mg, tid, d1-4; VP-16 75 mg/m2 d1-4; DDP 20mg/m2 d1-4; q3w. Efficacy was evaluated every two cycles. If patients hadn't diseases progression, two more cycles and radiation would be administered.
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age range 18-75 years old * Histological confirmed NK/T cell lymphoma * ECOG performance status less than 2 * Life expectancy of more than 3 months * None of major drugs in the trial (IFO,VP16,DDP) has been previously used * Normal laboratory values: hemoglobin \> 80 g/dl, neutrophil \> 2×109/L, platelet \> 100×109/L, serum creatine \< 1.5×upper limitation of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN
Exclusion criteria
* Pregnant or lactating women * Serious uncontrolled diseases and intercurrent infection * The evidence of CNS metastasis * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | every two cycles |
Secondary
| Measure | Time frame |
|---|---|
| TTP and OS | every two cycles |
Countries
China
Contacts
Primary ContactYe Guo, MD
Outcome results
None listed