New Combination Regimen of L-asparaginase, Dexamethasone, Ifosfamide, Cisplatin and Etoposide in NK/T-Cell Lymphoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma | Drug: L-asp, DXM, IFO, VP-16, DDP | Phase 2 |
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 |

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
|
- complete response rate [ Time Frame: 6 weeks ]
- Overall response rate, PFS and OS [ Time Frame: 6 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 14 Years to 75 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | 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:
- 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

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
Contact: Ye Guo, MD | 862164175590 | pattrick_guo@msn.com |
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 |
Principal Investigator: | Ye Guo, MD | Fudan University |
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 |