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:
Fudan University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: L-asp, DXM, IFO, VP-16, DDP |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Fudan University:
Primary Outcome Measures:
- complete response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall response rate, PFS and OS [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 76 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 14 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Ye Guo, Dr., Fudan University |
| ClinicalTrials.gov Identifier: | NCT00933673 History of Changes |
| Other Study ID Numbers: | LMTG 09-02 |
| Study First Received: | July 6, 2009 |
| Last Updated: | February 16, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by 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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013