Clinical trial · Interventional
Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma
An Open-Label, Uncontrolled, Single Centered Phase Ⅱ Study of Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone (Avastin+ GemAOD) As First-Line Treatment in Patients With Untreated NK/T Cell Lymphoma
NCT01921790CI-TRIAL-00011829unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal NK/T-cell Lymphoma, Nasal Type | Extranodal NK-/T-Cell Lymphoma, Nasal Type | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avastin | Biological | Bevacizumab | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Pegaspargase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avastin+ GemAOD
- description
- Avastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone
- interventionNames
- Biological: Avastin
- Drug: Gemcitabine
- Drug: Oxaliplatin
- Drug: Pegaspargase
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Overall Response Rate(ORR)
- timeFrame
- every 6 weeks,up to completion of treatment(approximately 6 months)
- description
- 21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles
Secondary outcomes (3)
- measure
- Progress Free Survival(PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of NK/T Cell Lymphoma; * Age:18-80 years; * Eastern Cooperative Oncology Group (ECOG) status 0-3, Estimated survival time \> 3 months; * Normal haematological, liver and renal function (WBC count≥4×109/L, Hemoglobin≥100g/L, platelet count≥100×109/L, bilirubin\<1.5×ULN, Alanine transaminase (ALT) or Aspartate Aminotransferase (AST)\<2.5×ULN, serum creatinine\<1.5×ULN), normal coagulation function and cardiac function; * Appreciable and measurable lesions ; * No history of other malignancies; * No previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation; * No other serious diseases which conflict with the treatment in the present trial; * No concurrent treatments that conflict with the treatments in the present trial(including steroid drugs); * Voluntary participation and signed the informed consent. Exclusion Criteria: * The patients had the conditions below: clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), symptomatic coronary artery heart disease requiring medication; * The patients suffered from organ transplant * The patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies; * The patients with active bleeding or new thrombotic disease, who are taking anticoagulant drugs or with a history of bleeding tendencies; * The patients suffered before surgery less than four weeks, or after less than six weeks; * The patients with major vascular invasion; * The patients with abnormal liver function (total bilirubin\> 1.5 times the normal value, ALT / AST\> 2.5 times normal), abnormal renal function (serum creatinine\> 1.5 times normal), blood abnormalities (absolute neutrophil count \<1.5 × 109 / L, platelets \<80 × 109 / L, hemoglobin \<90g /L) ; * The patients with moderate to severe proteinuria; * Severe hypertension,BP≥160/100mmHg; * The patients with mentally ill / unable to obtain informed consent; * The patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results; * The patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects; * Clinical and laboratory support brain metastases; * The patients with a history of allergy to test drug; * The patients not suitable to participate in the investigator judged by researchers.
References
Publications (0)
Data not yet available
No reference posted for this study.