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Extranodal NK/T-cell Lymphoma, Nasal TypePhase 2NCT01991158

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

A Phase 2 study testing High dose of methotrexate, Gemcitabine and Pegaspargase 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 The sponsor has not verified this record for over two years, so it may be out of date.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 High dose of Methotrexate combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line treatment in patients with de novo extranodal NK/T cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
High dose of methotrexate, Gemcitabine and Pegaspargase
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
Nov 2013to Nov 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;
  • Weight：Male：67±20Kg（47-87Kg），Female：55±20Kg（35-75Kg）
  • Eastern Cooperative Oncology Group (ECOG) status 0-3, Estimated survival time > 3 months;
  • No history of other malignancies; No other current tumors；
  • Normal haematological, liver and renal function (WBC count≥3.5×109/L, Hemoglobin≥100g/L, platelet count≥90×109/L, bilirubin<1.5×ULN, Alanine transaminase (ALT) and Aspartate Aminotransferase (AST)<2.5×ULN, serum creatinine<1.5×ULN), normal coagulation function and cardiac function;
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  • Clinical staging I-IV；
  • No previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation;
  • Appreciable and measurable lesions, clinical assessment >2cm，CT or MRI >1.5cm;
  • 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，who with active infection;
  • The patients suffered before surgery less than four weeks, or after less than six weeks;
  • 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) ;
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  • 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 or adverse reaction(s) to test drug;
  • The patients not suitable to participate in the investigator judged by researchers.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: An Open, Single-center, Phase II Clinical Trial for Treatment of Untreated Extranodal NK/T Cell Lymphoma With High Dose of Methotrexate in Combination With Gemcitabine, Pegaspargase and Dexamethasone (GAD-M Regimen)

The purpose of this study is to evaluate the efficacy and safety of High dose of Methotrexate combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line treatment in patients with de novo extranodal NK/T cell lymphoma.

Read the detailed description

Studies have shown that effects of P glycoprotein mediated chemotherapy resistance reduce the therapeutic efficacy of anthracycline-based chemotherapy of NK/T cell lymphoma, and agents like pegaspargase and large doses of Methotrexate is not affected by the P glycoprotein. A number of reports suggest that gemcitabine combined with other chemotherapy drugs has good application prospect in the treatment of lymphomas. 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 High dose of methotrexate combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line treatment in patients with untreated extranodal NK/T cell lymphoma.

Being tested
High dose of methotrexate, Gemcitabine, Pegaspargase, Dexamethasone
Keywords
GAD-M regimen, 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.

  • High dose of methotrexateDrug

    Methotrexate 3.0g/Kg, intravenous drip D1

  • GemcitabineDrug

    Gemcitabine 1g/m2 intravenous drip D1,D8

  • PegaspargaseDrug

    Pegaspargase 2500U/m2 intramuscular injection (IM) D1

  • DexamethasoneDrug

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

Study groups in NCT01991158
Study groupRoleWhat they receive
GAD-M regimenExperimentalGAD-M regimen means High dose of methotrexate combined with gemcitabine, pegaspargase and dexamethasone
Receives: Drug: High dose of methotrexate; Drug: Gemcitabine; 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 (2)

  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)

Timeline

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

  1. First posted25 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionDec 2016 (estimated)
  4. Study completionNov 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
NCT01991158
Sponsor's protocol ID
B2013-030-01
Status last verified
Jun 2016
First submitted
7 Nov 2013
Last updated
14 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang Y, Wang CQ, Sun P, Liu PP, Yang H, Wang HY, Rao HL, Li S, Jiang WQ, Huang JJ, Li ZM. Phase II Study of Gemcitabine, Peg-Asparaginase, Dexamethasone and Methotrexate Regimen for Newly Diagnosed Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type: Final Analysis With Long-Term Follow-Up and Rational Research for the Combination. Front Oncol. 2022 Jan 24;12:796738. doi: 10.3389/fonc.2022.796738. eCollection 2022.

    PubMed 35141162

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing High dose of methotrexate, Gemcitabine and Pegaspargase 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 12 inclusion and 12 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 14 Jun 2016. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT01991158, which also lists 1 linked publication.

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 14 Jun 2016.

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