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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
L-asp, DXM, IFO, VP-16, DDP
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring NK/T cell lymphoma, DICE, L-asparaginase

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

L-DICE

Arm Description

Outcomes

Primary Outcome Measures

complete response rate

Secondary Outcome Measures

Overall response rate, PFS and OS

Full Information

First Posted
July 6, 2009
Last Updated
February 16, 2012
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT00933673
Brief Title
New Combination Regimen of L-asparaginase, Dexamethasone, Ifosfamide, Cisplatin and Etoposide in NK/T-Cell Lymphoma
Official Title
Phase II Study of L-asparaginase Plus DICE Regimen in Patients With Stage I/II NK/T-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
NK/T cell lymphoma, DICE, L-asparaginase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-DICE
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
L-asp, DXM, IFO, VP-16, DDP
Other Intervention Name(s)
L-DICE
Intervention Description
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.
Primary Outcome Measure Information:
Title
complete response rate
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Overall response rate, PFS and OS
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Guo, MD
Phone
862164175590
Email
pattrick_guo@msn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD
Phone
862164175590
Email
pattrick_guo@msn.com
First Name & Middle Initial & Last Name & Degree
Ye Guo, MD

12. IPD Sharing Statement

Learn more about this trial

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

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