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

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ClinicalTrials.gov Identifier: NCT01921790
Recruitment Status : Recruiting
First Posted : August 13, 2013
Last Update Posted : August 22, 2013
Sponsor:
Collaborators:
Hoffmann-La Roche
Eli Lilly and Company
Information provided by (Responsible Party):
Li Zhiming, Sun Yat-sen University

Brief 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

Condition or disease Intervention/treatment Phase
Extranodal NK/T-cell Lymphoma, Nasal Type Biological: Avastin Drug: Gemcitabine Drug: Oxaliplatin Drug: Pegaspargase Drug: Dexamethasone Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Avastin+ GemAOD
Avastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone
Biological: Avastin
Avastin 7.5mg/Kg, intravenous drip D1

Drug: Gemcitabine
Gemcitabine 1g/m2 intravenous drip D1,D8

Drug: Oxaliplatin
Oxaliplatin 130mg/m2 intravenous drip D1

Drug: Pegaspargase
Pegaspargase 2500U/m2 intramuscular injection (IM) D1

Drug: Dexamethasone
Dexamethasone 20mg/d intravenous drip D1, po D2-3




Primary Outcome Measures :
  1. Overall Response Rate(ORR) [ Time Frame: every 6 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles


Secondary Outcome Measures :
  1. Progress Free Survival(PFS) [ Time Frame: up to end of follow-up-phase (approximately 5 years) ]
  2. Overall Survival(OS) [ Time Frame: up to the date of death (approximately 5 years) ]
  3. The tolerance and the side effects of the treatment [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle,Toxicity was evaluated every cycle


Other Outcome Measures:
  1. Epstein-Barr virus(EBV) DNA copies [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle

  2. lymphocyte count [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle

  3. Monocyte Count [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle

  4. C reactive protein [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle

  5. Plasma β2-microglobulin [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle

  6. Urinary microglobulin β2 [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921790


Contacts
Contact: Zhiming Li, MD 86-20-87343765 lizhm@sysucc.org.cn
Contact: Yu Wang, MD 86-20-87343349 wangyu@sysucc.org.cn

Locations
China, Guangdong
Department of Medical Oncology, Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhiming Li, MD    +86-13719189172    lizhm@sysucc.org.cn   
Contact: Yu Wang, MD    +86-20-87343765    wangyu@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Hoffmann-La Roche
Eli Lilly and Company
Investigators
Principal Investigator: 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

Responsible Party: Li Zhiming, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01921790     History of Changes
Other Study ID Numbers: B2013-017-01
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013

Keywords provided by Li Zhiming, Sun Yat-sen University:
Avastin+ GemAOD
first line chemotherapy
NK/T-cell Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone acetate
Dexamethasone
Gemcitabine
Oxaliplatin
Pegaspargase
Bevacizumab
Asparaginase
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors