Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of avastin combined with gemcitabine, oxaliplatin, pegaspargase and dexamethasone(Avastin+ GemAOD) as first-line treatment in patients with untreated natural killer(NK)/T cell lymphoma
Recent study showed that vascular endothelial growth factor (VEGF) was associated with a poorer outcome in patients with Non-Hodgkin's Lymphoma,and Avastin impacted on tumor endothelial cells to make standard chemotherapy work better for T cell lymphoma. Many researches on Gemcitabine combined with Oxaliplatin for treatments of recurrent and refractory Non-Hodgkin's lymphoma showed patients could benefit from the combination treatment . Pegaspargase plays an important role for treatment of NK/T cell lymphoma. Dexamethasone is used in combination with other agents for the treatment of lymphomas which may be implicated in the development or growth of some cancers.So we explored to evaluate the efficacy and safety of Avastin combined with gemcitabine, oxaliplatin, pegaspargase and dexamethasone(Avastin+ GemAOD) as first-line treatment in patients with untreated NK/T cell lymphoma
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avastin+ GemAOD | Experimental | Avastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avastin | Biological | Avastin 7.5mg/Kg, intravenous drip D1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate(ORR) | 21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles | every 6 weeks,up to completion of treatment(approximately 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progress Free Survival(PFS) | up to end of follow-up-phase (approximately 5 years) | |
| Overall Survival(OS) | up to the date of death (approximately 5 years) | |
| The tolerance and the side effects of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Epstein-Barr virus(EBV) DNA copies | 21 days(3 weeks) for one cycle | every 3 weeks,up to completion of treatment(approximately 6 months) |
| lymphocyte count | 21 days(3 weeks) for one cycle |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiming Li, MD | Contact | 86-20-87343765 | lizhm@sysucc.org.cn | |
| Yu Wang, MD | Contact | 86-20-87343349 | wangyu@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wenqi Jiang, MD | Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China | Principal Investigator |
| Zhiming Li, MD | Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology, Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
Not provided
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| C042705 | pegaspargase |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gemcitabine |
| Drug |
Gemcitabine 1g/m2 intravenous drip D1,D8 |
|
| Oxaliplatin | Drug | Oxaliplatin 130mg/m2 intravenous drip D1 |
|
| Pegaspargase | Drug | Pegaspargase 2500U/m2 intramuscular injection (IM) D1 |
|
| Dexamethasone | Drug | Dexamethasone 20mg/d intravenous drip D1, po D2-3 |
|
21 days(3 weeks) for one cycle,Toxicity was evaluated every cycle |
| every 3 weeks,up to completion of treatment(approximately 6 months) |
| every 3 weeks,up to completion of treatment(approximately 6 months) |
| Monocyte Count | 21 days(3 weeks) for one cycle | every 3 weeks,up to completion of treatment(approximately 6 months) |
| C reactive protein | 21 days(3 weeks) for one cycle | every 3 weeks,up to completion of treatment(approximately 6 months) |
| Plasma β2-microglobulin | 21 days(3 weeks) for one cycle | every 3 weeks,up to completion of treatment(approximately 6 months) |
| Urinary microglobulin β2 | 21 days(3 weeks) for one cycle | every 3 weeks,up to completion of treatment(approximately 6 months) |
| Principal Investigator |
| D009369 |
| Neoplasms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |