Lymphoma, Extranodal NK-T-Cell Clinical Trial
Official title:
A Study of Gemcitabine, L- Asparaginase, Ifosfamide, Dexamethasone and Etoposide Chemotherapy Followed by ASCT for Newly Diagnosed Stage IV, Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma, Nasal Type
Verified date | November 2017 |
Source | Sichuan University |
Contact | Jie Ji, MD |
Phone | 86-28-85422370 |
jieji[@]scu.edu.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is to explore the efficacy and safety of GLIDE regiment in patients with aggressive NK/T cell lymphoma.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 30, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. diagnosis of ENKL defined by World Health Organization classification 2008; 2. age above 18 years; 3. Eastern Cooperative Oncology Group performance status of 0-3; 4. adequate organ function defined as: total bilirubin=2 times the upper limit of normal; alanine aminotransferase and aspartate aminotransferase levels=2.5 times the upper limit of normal; serum creatinine=1.5 mg/dL; creatinine clearance =50 mL/minute and normal electrocardiogram results. Exclusion Criteria: 1. uncontrolled infection; 2. pregnant or lactating women; 3. contraindication to one of the trial drugs (eg. anaphylaxis to L-asparaginase); 4. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital of Sichuan University | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Sichuan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PFS | 2-year progression free survival | 2 years after recruitment | |
Secondary | CR | complete remission | 2 and 6 month after GLIDE, and 3 month after ASCT | |
Secondary | AEs | adverse events | 2 years after recruitment | |
Secondary | OS | 2-year overall survival | 2 years after recruitment |
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