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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00933673
• Other study ID #: LMTG 09-02
• Status: Recruiting
• Phase: Phase 2
• First received: July 6, 2009
• Last updated: February 16, 2012
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: February 2012
• Source: Fudan University
• Contact: Ye Guo, MD
• Phone: 862164175590
• Email: pattrick_guo[@]msn.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell

Intervention

Drug:
• L-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.

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response rate		6 weeks	No
Secondary	Overall response rate, PFS and OS		6 weeks	No