AzTrials
AzTrials

Lymphoma, Extranodal NK-T-CellPhase 2NCT02533323

P-Gemox Regimen as First-line Chemotherapy in NK/T Lymphoma Patiens

A Phase 2 study testing gemcitabine, oxaliplatin and pegaspargase in people with Lymphoma, Extranodal NK-T-Cell, run by Sun Yat-sen University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This prospective study was conducted to evaluate the efficacy and safety profiles of first-line combined gemcitabine, oxaliplatin, and Pegaspargase (P-Gemox) in newly diagnosed, nasal type, extranodal natural killer/T-cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lymphoma, Extranodal NK-T-Cell
What is being tested?
gemcitabine, oxaliplatin and pegaspargase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
Jan 2012to Jan 2017
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

  • newly diagnosed ENKTL
  • age:18-80years
  • at lease one measurable lesion
  • receive no chemotherapy or radiotherapy before
  • Eastern CooperativeOncology Group performance status of 0 to 2.
  • Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Who cannot join

  • mismatch the inclusion criteria
  • systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Phase 2 Trial of Pegaspargase-Gemox Chemotherapy in Newly Diagnosed, Nasal Type, Extranodal Natural Killer/T-cell Lymphoma

This prospective study was conducted to evaluate the efficacy and safety profiles of first-line combined gemcitabine, oxaliplatin, and Pegaspargase (P-Gemox) in newly diagnosed, nasal type, extranodal natural killer/T-cell lymphoma.

Read the detailed description

Treatment P-Gemox dosages were as follows: days 1, 30 min intravenous infusion of 1250 mg/m2 gemcitabine; day 1, 2h intravenous infusion of 85 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2500 U/m2 PEG-ASP at three different sites. The regimen was repeated every 2 weeks for a maximum of six cycles. 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 patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Primary tumor radiotherapy was recommended after they achieved CR.

Being tested
gemcitabine, oxaliplatin, pegaspargase
Keywords
NK/T-cell lymphoma, induction chemotherapy, survival
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.

  • gemcitabineDrug

    Also called Gemzar

    gemcitabine :1250mg/m2 (ivdrip) on days 1

  • oxaliplatinDrug

    Also called Eloxatin

    oxaliplatin :85 mg/m2 (ivdrip) on day 1

  • pegaspargaseDrug

    Also called Oncaspar

    pegaspargase : 2500 IU/m2 (intramuscular injection)

Study groups in NCT02533323
Study groupRoleWhat they receive
P-GemoxExperimentalP-Gemox:gemcitabine :1250mg/m2 (ivdrip) on days 1, oxaliplatin :85 mg/m2 (ivdrip) on day 1, and pegaspargase : 2500 IU/m2 (intramuscular injection) on day 1.Cycle is repeated every 14 days.
Receives: Drug: gemcitabine; Drug: oxaliplatin; Drug: pegaspargase

What is being measured

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

  1. progression free survival

    time from the date of enrollment to date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first

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

Secondary outcomes (6)

  1. complete remission rate

    The criteria for the efficacy evaluation (overall response rate and complete remission) of the regimen is according to the following article:

    Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999;17:1244.

    Measured: every 4 weeks,up to completion of treatment(approximately 6 months)

  2. overall survival

    overall survival (OS): time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first

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

  3. safety, as measured by adverse events

    ncluding hematological safety and non-hematological safety.All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

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

  4. serum soluble programmed death ligand 1

    Soluble PD-L1 is measured using an enzyme-linked immunosorbent assay

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

  5. serum interleukin 15

    serum interleukin 15 is measured using an enzyme-linked immunosorbent assay

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

  6. Serum ferritin level

    Serum ferritin level is measured using radioimmunoassay

    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 posted26 Aug 2015 (estimated)
  2. Study startJan 2012
  3. Primary completionSep 2016
  4. Study completionJan 2017

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02533323
Sponsor's protocol ID
SYSUCC-NK/T-5010
Status last verified
Oct 2016
First submitted
24 Aug 2015
Last updated
9 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine, oxaliplatin and pegaspargase in people with Lymphoma, Extranodal NK-T-Cell, 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 9 May 2018. 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?

The study was stopped early. 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?

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 NCT02533323.

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 9 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in