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Treatment RefusalPhase 2NCT02705508

PEG-ASP, Etoposide and Gemcitabine for Natural Killer/T Lymphoma

A Phase 2 study testing Gemcitabine, etoposide and Pegaspargase in people with Treatment Refusal, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the efficacy and safety of pegylated aspargase(PEG-ASP)combined with etoposide and gemcitabine (PEG) treatment in this population. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Treatment Refusal
What is being tested?
Gemcitabine, etoposide and Pegaspargase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
Feb 2016to Dec 2023
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

  • pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification;
  • age≥18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • at least one measurable lesion;
  • adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l),
  • adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal),
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  • adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);
  • normal coagulation function and electrocardiogram results.
  • Prior chemotherapy and radiotherapy should have been completed >4 weeks 10.earlier,willingness to provide written informed consent.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

hua wang, MD. contact

0086-02087342462

wanghua@sysucc.org.cn

hua wang, MD. contact

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Please Select, 510060

    hua wang, MD., 0086-02087342462, wanghua@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Phase 2 Trial of PEG-ASP Combined With Etoposide and Gemcitabine (PEG) as First-line Chemotherapy to Treat NK/T-cell Lymphoma

Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the efficacy and safety of pegylated aspargase(PEG-ASP)combined with etoposide and gemcitabine (PEG) treatment in this population.

Read the detailed description

Treatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500unit/m2 PEG-ASP at three different sites.The regimen was repeated every 3 weeks.Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got complete remission ,partial regression or stable disease.Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved-field radiation (IFRT) dose was 50-56 Gy.Stage IIIE/IVE patients were given for a maximum of six cycles.Refractory/relapsed patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Autologous haematopoietic stem cell transplantation (AHSCT) was recommended after achieving CR for advanced stage and refractory/relapsed patients

Being tested
Gemcitabine, etoposide, Pegaspargase, involved-field radiotherapy
Keywords
extranodal natural killer/T-cell lymphoma, nasal type, chemotherapy, radiotherapy
Medical subject headings
Treatment Refusal

What participants receive

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

  • GemcitabineDrug

    Also called Gemzar

    1000mg/m2, ivd on day 1 and 8 of each 21 day cycle.

  • etoposideDrug

    Also called Etoposide phosphate

    100mg/m2，4h-intravenous infusion on day1-3 of each 21 day cycle.

  • PegaspargaseDrug

    Also called Oncaspar

    2500U/m2 im on day 1 of each 21 day cycle.

  • involved-field radiotherapyRadiation

    Also called IFRT

    Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy.

Study groups in NCT02705508
Study groupRoleWhat they receive
PEG groupExperimentalTreatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500U/m2 Pegaspargase at three different sites.The regimen was repeated every 3 weeks.Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved-field radiation (IFRT) dose was 50-56 Gy.Stage IIIE/IVE patients were given for a maximum of six cycles.
Receives: Drug: Gemcitabine; Drug: etoposide; Drug: Pegaspargase; Radiation: involved-field radiotherapy

What is being measured

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

  1. progression free survival

    Measured: up to end of follow-up-phase (approximately 3 years)

Secondary outcomes (2)

  1. overall survival

    Measured: up to end of follow-up-phase (approximately 3 years)

  2. complete remission rate

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

Timeline

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

  1. First posted10 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (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
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02705508
Sponsor's protocol ID
NK-SYSUCC-2016
Status last verified
Jun 2023
First submitted
7 Mar 2016
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Feng D, Yan Z, Fu B, Bai S, Zhu L, Gale RP, Xia Z, Liang Y, Wang H. Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma. Hematology. 2024 Dec;29(1):2402102. doi: 10.1080/16078454.2024.2402102. Epub 2024 Sep 13.

    PubMed 39268981

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, etoposide and Pegaspargase in people with Treatment Refusal, 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 9 inclusion and 1 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 18 Jun 2023. 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 hua wang, MD. (0086-02087342462, wanghua@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: up to end of follow-up-phase (approximately 3 years)). 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 NCT02705508, 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 18 Jun 2023.

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