Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-TypePhase 3NCT02085655

PEG-ASP+Gemox Regimen and Thalidomide for NK/T Lymphoma

A Phase 3 study testing pegaspargase, Gemcitabine and Oxaliplatin in people with Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type, run by Huiqiang Huang 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 The sponsor has not verified this record for over two years, so it may be out of date.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 long-acting aspargase (pegylated aspargase, PEG-ASP) combined with gemcitabine and oxaliplatin (PASP -Gemox) treatment… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
What is being tested?: pegaspargase, Gemcitabine and Oxaliplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 264 participants
Where: 1 siteChina
Study dates: 25 Apr 2013to 31 Dec 2022
Phase: Phase 3
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 75 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 earlier,
willingness to provide written informed consent.

Who cannot join

Trial locations and contacts

1 site in 1 country.

HuiQiang Huang contact

86-020-87343350

huanghq@sysucc.org.cn

China1 site, 1 recruiting

Department of Medical Oncology, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, 510060
HuiQiang Huang, 86-020-87343350, huanghq@sysucc.org.cn
Recruiting

Other trials in China

About this study

Official title: PA-Gemox Regimen Followed by Thalidomide Versus AspaMetDex Regimen in NKTCL Patients：a Randomized, Open-label, Phase 3 Study

Read the detailed description

Eligibility criteria The eligibility criteria were 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), 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), 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 earlier, willingness to provide written informed consent. Stage was defined according to the Ann Arbor system. The Sun Yat-Sen University Cancer Centre Research Ethics Board approved this study before subjects were enrolled.

Treatment PA-Gemox dosages were as follows: days 1 and 8, 30-min intravenous infusion of 1000 mg/m2 gemcitabine; day 1, 2-h intravenous infusion of 130 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2500 U/m2 PEG-ASP at two different sites. The regimen was repeated every 3 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. 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 they achieved CR.

Conditions: Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
Being tested: pegaspargase, Gemcitabine, Oxaliplatin, Methotrexate, Dexamethasone
Keywords: Extranodal NK/T-cell lymphoma, PA-Gemox regimen, thalidomide
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.

pegaspargaseDrug
Also called Oncaspar
pegaspargase: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
GemcitabineDrug
Also called Gemzar
1000mg/m2, ivd on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
OxaliplatinDrug
Also called Eloxatin
100mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops
MethotrexateDrug
3000m g/m2 civ 6-hour on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
DexamethasoneDrug
40mg ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
ThalidomideDrug
100-200mg, PO, after chemotherapy

Study groups in NCT02085655
Study group	Role	What they receive
PEG-ASP+Gemox regimen group	Experimental	PEG-ASP 2000U/m2 im d1 Gemcitabine 800mg/m2 ivdrip 30min d1，8 Oxaliplatin 100mg/m2 ivdrip d1 Thalidomide 150-200mg po qn d8-21 Receives: Drug: pegaspargase; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Thalidomide
AspaMetDex regimen group	Active comparator	Pegaspargase 2000U/m2 im， d1 methotrexate 3000m g/m2 civ 6-hour，d1, Calcium folinate 30mg iv q6h x6 Dexamethasone 40 mg ivdrip QD Receives: Drug: pegaspargase; Drug: Methotrexate; Drug: Dexamethasone

What is being measured

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

Efficacy Outcome Measure
Study group increase 15% 2-year PFS
Measured: up to 24 months

Secondary outcomes (1)

Safety/Adverse Event Outcome Measure
Number of Participants with Serious and Non-Serious Adverse Events
Measured: Up to 36 months

Timeline

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

25 Apr 201331 Dec 2022

First posted13 Mar 2014 (estimated)
Study start25 Apr 2013
Primary completion31 Dec 2022 (estimated)
Study completion31 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-TypeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 264 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02085655
Sponsor's protocol ID: NKT-SYSUCC-2013
Status last verified: Mar 2021
First submitted: 11 Mar 2014
Last updated: 15 Mar 2021
Results posted: No
Data monitoring committee: Yes

Want to know more?

HuiQiang Huang

86-020-87343350

huanghq@sysucc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of Pembrolizumab in Patients With Early-Stage NK/T-cell Lymphoma, Nasal Type
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All Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PA-Gemox Regimen Followed by Thalidomide Versus AspaMetDex Regimen in NKTCL Patients：a Randomized, Open-label, Phase 3 Study
ClinicalTrials.gov ID: NCT02085655
Acronym / sponsor ID: NKT-SYSUCC-2013
Conditions: Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
Keywords: Extranodal NK/T-cell lymphoma, PA-Gemox regimen, thalidomide
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 264 participants (estimated)
Lead sponsor: Huiqiang HuangUniversity, hospital or other
Collaborators: Sun Yat-sen University
Study start: 25 Apr 2013 (actual)
Primary completion: 31 Dec 2022 (estimated)
Study completion: 31 Dec 2022 (estimated)
First posted: 13 Mar 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PEG-ASP+Gemox regimen group	Experimental	Drug: pegaspargase, Drug: Gemcitabine, Drug: Oxaliplatin, Drug: ThalidomidePEG-ASP 2000U/m2 im d1 Gemcitabine 800mg/m2 ivdrip 30min d1，8 Oxaliplatin 100mg/m2 ivdrip d1 Thalidomide 150-200mg po qn d8-21
AspaMetDex regimen group	Active comparator	Drug: pegaspargase, Drug: Methotrexate, Drug: DexamethasonePegaspargase 2000U/m2 im， d1 methotrexate 3000m g/m2 civ 6-hour，d1, Calcium folinate 30mg iv q6h x6 Dexamethasone 40 mg ivdrip QD

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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),

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pegaspargaseAlso: Oncasparpegaspargase: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.	Drug	AspaMetDex regimen group, PEG-ASP+Gemox regimen group
GemcitabineAlso: Gemzar1000mg/m2, ivd on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.	Drug	PEG-ASP+Gemox regimen group
OxaliplatinAlso: Eloxatin100mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops	Drug	PEG-ASP+Gemox regimen group
Methotrexate3000m g/m2 civ 6-hour on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.	Drug	AspaMetDex regimen group
Dexamethasone40mg ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.	Drug	AspaMetDex regimen group
Thalidomide100-200mg, PO, after chemotherapy	Drug	PEG-ASP+Gemox regimen group

Primary outcome

Efficacy Outcome Measure
Time frame: up to 24 months
Study group increase 15% 2-year PFS

1 secondary outcome

Safety/Adverse Event Outcome Measure
Time frame: Up to 36 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.

Related trials for Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type

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Active, not recruitingPhase 2
Study of Pembrolizumab in Patients With Early-Stage NK/T-cell Lymphoma, Nasal Type
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Active, not recruitingPhase 1/2
A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
Relapsed or Refractory T-cell Lymphomas

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

HuiQiang Huang contact

86-020-87343350

huanghq@sysucc.org.cn

HuiQiang Huang study chair

Sun Yat-sen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pegaspargase, Gemcitabine and Oxaliplatin in people with Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type, run by Huiqiang Huang 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 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 15 Mar 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 HuiQiang Huang (86-020-87343350, huanghq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Outcome Measure (time frame: up to 24 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 NCT02085655.

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 15 Mar 2021.