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

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ClinicalTrials.gov Identifier: NCT00933673
Recruitment Status : Unknown
Verified February 2012 by Ye Guo, Fudan University.
Recruitment status was:  Recruiting
First Posted : July 7, 2009
Last Update Posted : February 20, 2012
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: L-asp, DXM, IFO, VP-16, DDP Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of L-asparaginase Plus DICE Regimen in Patients With Stage I/II NK/T-cell Lymphoma
Study Start Date : June 2009
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: L-DICE 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


Outcome Measures
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Primary Outcome Measures :
  1. complete response rate [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Overall response rate, PFS and OS [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933673


Contacts
Contact: Ye Guo, MD 862164175590 pattrick_guo@msn.com

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ye Guo, MD    862164175590    pattrick_guo@msn.com   
Principal Investigator: Ye Guo, MD         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Ye Guo, MD Fudan University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Ye Guo, Dr., Fudan University
ClinicalTrials.gov Identifier: NCT00933673     History of Changes
Other Study ID Numbers: LMTG 09-02
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012

Keywords provided by Ye Guo, Fudan University:
NK/T cell lymphoma
DICE
L-asparaginase

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Asparaginase
Antineoplastic Agents