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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

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

NCT ID

NCT00933673

First Posted

July 6, 2009

Last Updated

February 16, 2012

Sponsor

Fudan University

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

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

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

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

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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