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UNKNOWNPHASE2

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

NCT01921790•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

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

Detailed Description

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+5 more criteria

Locations (1)

Department of Medical Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

August 1, 2013

Primary Completion Date

August 1, 2015

Completion Date

August 1, 2020

Last Updated

August 22, 2013

Enrollment

ESTIMATED participants

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Interventions

Avastin

BIOLOGICAL

Gemcitabine

DRUG

Oxaliplatin

DRUG

Pegaspargase

DRUG

Dexamethasone

DRUG

Contacts

Zhiming Li, MD

CONTACT

86-20-87343765 lizhm@sysucc.org.cn

Yu Wang, MD

CONTACT

86-20-87343349 wangyu@sysucc.org.cn

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

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Peripheral T Cell LymphomaPTCL+17 more

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TERMINATEDPHASE1/PHASE2

Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL

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Extranodal NK/T-cell Lymphoma, Nasal Type

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL

Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL

GAD-M Regimen As First-Line Treatment in Untreated Extranodal NK/T Cell Lymphoma

Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma