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Extranodal NK/T-cell Lymphoma, Nasal TypePhase 2NCT01921790

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

A Phase 2 study testing Avastin, Gemcitabine and Oxaliplatin in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Avastin, Gemcitabine and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Aug 2013to Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Zhiming Li, MD contact

86-20-87343765

lizhm@sysucc.org.cn

Yu Wang, MD contact

86-20-87343349

wangyu@sysucc.org.cn

China1 site, 1 recruiting

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

    Guangzhou, Guangdong, 510060

    Zhiming Li, MD, +86-13719189172, lizhm@sysucc.org.cn

    Yu Wang, MD, +86-20-87343765, wangyu@sysucc.org.cn

    Recruiting

Other trials in China

About this study

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

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

Read the 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

Being tested
Avastin, Gemcitabine, Oxaliplatin, Pegaspargase, Dexamethasone
Keywords
Avastin+ GemAOD, first line chemotherapy, NK/T-cell Lymphoma
Medical subject headings
Lymphoma, Extranodal NK-T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvastinBiological

    Avastin 7.5mg/Kg, intravenous drip D1

  • GemcitabineDrug

    Gemcitabine 1g/m2 intravenous drip D1,D8

  • OxaliplatinDrug

    Oxaliplatin 130mg/m2 intravenous drip D1

  • PegaspargaseDrug

    Pegaspargase 2500U/m2 intramuscular injection (IM) D1

  • DexamethasoneDrug

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

Study groups in NCT01921790
Study groupRoleWhat they receive
Avastin+ GemAODExperimentalAvastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone
Receives: Biological: Avastin; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Pegaspargase; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate(ORR)

    21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles

    Measured: every 6 weeks,up to completion of treatment(approximately 6 months)

Secondary outcomes (3)

  1. Progress Free Survival(PFS)

    Measured: up to end of follow-up-phase (approximately 5 years)

  2. Overall Survival(OS)

    Measured: up to the date of death (approximately 5 years)

  3. The tolerance and the side effects of the treatment

    21 days(3 weeks) for one cycle,Toxicity was evaluated every cycle

    Measured: every 3 weeks,up to completion of treatment(approximately 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionAug 2015 (estimated)
  4. Study completionAug 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01921790
Sponsor's protocol ID
B2013-017-01
Status last verified
Aug 2013
First submitted
3 Aug 2013
Last updated
22 Aug 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avastin, Gemcitabine and Oxaliplatin in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhiming Li, MD (86-20-87343765, lizhm@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate(ORR) (time frame: every 6 weeks,up to completion of treatment(approximately 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01921790.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2013.

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