New Combination Regimen of L-asparaginase, Dexamethasone, Ifosfamide, Cisplatin and Etoposide in NK/T-Cell Lymphoma

Phase II Study of L-asparaginase Plus DICE Regimen in Patients With Stage I/II NK/T-cell Lymphoma

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00933673

Enrollment

Registered

2009-07-07

Start date

2009-06-30

Completion date

2012-06-30

Last updated

2012-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

NK/T cell lymphoma, DICE, L-asparaginase

Brief summary

The purpose of this study is to evaluate the efficacy and tolerability of the combination chemotherapy of L-asparaginase plus DICE regimen in the patients with early stage NK/T-cell lymphoma.

Detailed description

DICE regimen was found to be highly effective as induction chemotherapy in patients with early stage NK/T-cell lymphoma in the ongoing study. L-asparaginase, an agent with unique anti-cancer mechanism, was also found to be effective in salvage setting. In terms of non-overlapped efficacy and toxicity, the investigators designed this phase II study to verify the efficacy and tolerability of this new combination.

Interventions

DRUGL-asp, DXM, IFO, VP-16, DDP

L-asp 6000 u/m2; DXM 40 mg d1-4; IFO 1200mg/m2 d1-4; Mesna 400mg, tid, d1-4; VP-16 60 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Age range 14-75 years old * Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract * ECOG performance status less than 2 * Life expectancy of more than 3 months * 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
complete response rate	6 weeks

Secondary

Measure	Time frame
Overall response rate, PFS and OS	6 weeks

Countries

China

Contacts

Primary ContactYe Guo, MD

pattrick_guo@msn.com862164175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026