Text Size

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

This study is currently recruiting participants.
Verified February 2012 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT00933673
First received: July 6, 2009
Last updated: February 16, 2012
Last verified: February 2012
History of Changes

July 6, 2009
February 16, 2012
June 2009
June 2012   (final data collection date for primary outcome measure)
complete response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
complete response rate [ Time Frame: every two cycles ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00933673 on ClinicalTrials.gov Archive Site
Overall response rate, PFS and OS [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Overall response rate, PFS and OS [ Time Frame: every two cycles ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
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.
Other Name: L-DICE
Experimental: L-DICE
Intervention: Drug: L-asp, DXM, IFO, VP-16, DDP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
14 Years to 75 Years
No
Contact: Ye Guo, MD 862164175590 pattrick_guo@msn.com
China
 
NCT00933673
LMTG 09-02
No
Ye Guo, Fudan University
Fudan University
Not Provided
Principal Investigator: Ye Guo, MD Fudan University
Fudan University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP