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Status unknownNCT00933673Updated Feb 20, 2012

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

A Phase 2 interventional study of L-asp, DXM, IFO, VP-16, DDP in Lymphoma, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-02-20.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
76
Allocation
Not applicable
Ages
14 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lymphoma

Keywords

  • NK/T cell lymphoma
  • DICE
  • L-asparaginase
03

In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 76 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    L-DICE

    Drug: L-asp, DXM, IFO, VP-16, DDP

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.

    Also known as: L-DICE

06

What researchers measure

Primary outcomes

  1. complete response rate

    Time frame: 6 weeks

Secondary outcomes

  1. Overall response rate, PFS and OS

    Time frame: 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Fudan University Cancer Hospital
    Shanghai, Shanghai 200032, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00933673
Lead sponsor
Fudan University
Responsible party
Ye Guo (Dr., Fudan University) — Principal investigator
First posted
Jul 7, 2009
Start date
Jun 2009
Primary completion
Jun 2012 (estimated)
Completion
Jun 2012 (estimated)
Last update
Feb 20, 2012

Study contacts

Ye Guo, MD
Contact
pattrick_guo@msn.com
862164175590
Ye Guo, MD
principal investigator · Fudan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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