Nasal and Nasal-type NK/T-cell LymphomaPhase 4CTTNKTL-Ⅲ/ⅣNCT01501149
Treatment of Natural Killer/T Cell Lymphoma-Ⅲ/Ⅳ
A Phase 4 study testing DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase) and Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna） in people with Nasal and Nasal-type NK/T-cell Lymphoma, run by Mingzhi Zhang at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural Killer (NK)/T Cell Lymphoma. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Nasal and Nasal-type NK/T-cell Lymphoma
- What is being tested?
- DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase) and Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to May 2019
- Phase
- Phase 4
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months
- Histological confirmed NK/T cell lymphoma
- None of chemotherapy or radiotherapy has been previously used
- None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups )
- At least one measurable lesion
- None of other serious diseases, cardiopulmonary function is normal
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- Pregnancy test of women at reproductive age must be negative
- Patients could be followed up
- None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
- volunteers who signed informed consent.
Who cannot join
- Disagreement on blood sample collection
- Patients allergic of any of drug in this regimen or with metabolic disorder
- Pregnant or lactating women
- Serious medical illness likely to interfere with participation
- Serious infection
- Primitive or secondary tumors of central nervous system
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- Chemotherapy or radiotherapy contraindication
- The evidence of CNS metastasis
- History of peripheral nervous disorder or dysphrenia
- patients participating in other clinical trials
- patients taking other antitumor drugs
- patients estimated to be unsuitable by investigator
Trial locations and contacts
1 site in 1 country.
Mingzhi Zhang, Pro,Dr contact
China1 site, 1 recruiting
- Recruiting
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mingzhi Zhang, Pro,Dr, mingzhi_zhang@126.com
Mingzhi Zhang, Pro,Dr
About this study
Official title: A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage Ⅲ/Ⅳ NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone)
The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural Killer (NK)/T Cell Lymphoma.
Read the detailed description
Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment DDGP (gemcitabine，pegaspargase, cisplatin, dexamethasone) in the patients with stage Ⅲ/Ⅳ NK/T cell lymphoma.
- Conditions
- Nasal and Nasal-type NK/T-cell Lymphoma
- Being tested
- DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase), Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）
- Keywords
- NK/T cell lymphoma, chemotherapy, clinical trial, RR, PFS, OS
- 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.
DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)Drug
Also called DDGP regiment
DDP 20 mg/m2,ivgtt（intravenously guttae）,d1-4;DEX 15mg/m2,ivgtt,d1-5;GEM 800mg/m2,ivgtt,30min,d1,8;Pegasparaginase,im,2500IU/m2 d1.Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles.
Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）Drug
Also called Modified SMILE regiment
MTX,2g/m2 (20% ivgtt（intravenously guttae）,2h;80% ivgtt,4h), d1;DEX,40mg,ivgtt,d2-4;IFO,1.5g/m2,ivgtt,d2-4;L-ASP,6000U/m2,ivgtt,d3-9;VP-16,100mg/m2,ivgtt,d2-4; Mesna,0、4、8h after IFO, 240mg/m2,iv,d2-4.Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles.
| Study group | Role | What they receive |
|---|---|---|
| DDGP regiment | Experimental | DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment Receives: Drug: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase) |
| SMILE Regiment | Experimental | Modified SMILE （methotrexate，hexadecadrol，Ifosfamide，L-AsparaginaseL，Etoposide，Mesna）Regiment Receives: Drug: Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: up to end of follow-up-phase (approximately 24 months)
Secondary outcomes (3)
response rate
21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles.
Measured: every 6 weeks,up to completion of treatment(approximately 18 weeks )
overall survival
Measured: up to the date of death (approximately 5 years)
median survival time
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2015 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nasal and Nasal-type NK/T-cell LymphomaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingzhi Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Second Hospital of Shanxi Medical University, Shanxi Province Cancer Hospital, Wuhan University, Wuhan TongJi Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Qingdao University, Cancer Hospital of Guizhou Province, Xinyang Central Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Mingzhi Zhang, Zhengzhou University
- Investigators
- Mingzhi Zhang, Pro，Dr, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501149
- Sponsor's protocol ID
- hnslblzlzx2011-2
- Acronym
- CTTNKTL-Ⅲ/Ⅳ
- Status last verified
- Jul 2015
- First submitted
- 29 Nov 2011
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang X, Zhang L, Liu X, Li X, Li L, Fu X, Sun Z, Wu J, Zhang X, Yan J, Chang Y, Nan F, Zhou Z, Wu X, Tian L, Ma M, Li Z, Yu H, Zhu L, Wang Y, Shi C, Feng X, Li J, Ding M, Zhang J, Dong M, Xue H, Wang J, Zou L, Su L, Wu J, Liu L, Bao H, Zhang L, Guo Y, Guo S, Lu Y, Young KH, Li W, Zhang M. Efficacy and Safety of a Pegasparaginase-Based Chemotherapy Regimen vs an L-asparaginase-Based Chemotherapy Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-Cell Lymphoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1035-1041. doi: 10.1001/jamaoncol.2022.1968.
PubMed 35708709Zhao Q, Fan S, Chang Y, Liu X, Li W, Ma Q, Li Y, Wang Y, Zhang L, Zhang M. Clinical efficacy of cisplatin, dexamethasone, gemcitabine and pegaspargase (DDGP) in the initial treatment of advanced stage (stage III-IV) extranodal NK/T-cell lymphoma, and its correlation with Epstein-Barr virus. Cancer Manag Res. 2019 Apr 24;11:3555-3564. doi: 10.2147/CMAR.S191929. eCollection 2019.
PubMed 31118779Zhang L, Jia S, Ma Y, Li L, Li X, Wang X, Fu X, Ma W, Qin Y, Li W, Wu J, Sun Z, Zhang X, Nan F, Chang Y, Li Z, Zhang D, Wang G, Yan J, Su L, Wang J, Xue H, Young KH, Zhang M. Efficacy and safety of cisplatin, dexamethasone, gemcitabine and pegaspargase (DDGP) regimen in newly diagnosed, advanced-stage extranodal natural killer/T-cell lymphoma: interim analysis of a phase 4 study NCT01501149. Oncotarget. 2016 Aug 23;7(34):55721-55731. doi: 10.18632/oncotarget.10124.
PubMed 27384676Li X, Cui Y, Sun Z, Zhang L, Li L, Wang X, Wu J, Fu X, Ma W, Zhang X, Chang Y, Nan F, Li W, Su L, Wang J, Xue H, Zhang M. DDGP versus SMILE in Newly Diagnosed Advanced Natural Killer/T-Cell Lymphoma: A Randomized Controlled, Multicenter, Open-label Study in China. Clin Cancer Res. 2016 Nov 1;22(21):5223-5228. doi: 10.1158/1078-0432.CCR-16-0153. Epub 2016 Apr 8.
PubMed 27060152
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage Ⅲ/Ⅳ NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone)
- ClinicalTrials.gov ID
- NCT01501149
- Acronym / sponsor ID
- CTTNKTL-Ⅲ/Ⅳ / hnslblzlzx2011-2
- Conditions
- Nasal and Nasal-type NK/T-cell Lymphoma
- Keywords
- NK/T cell lymphoma, chemotherapy, clinical trial, RR, PFS, OS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mingzhi ZhangUniversity, hospital or other
- Collaborators
- Second Hospital of Shanxi Medical University, Shanxi Province Cancer Hospital, Wuhan University, Wuhan TongJi Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Qingdao University, Cancer Hospital of Guizhou Province, Xinyang Central Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 29 Dec 2011 (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.
The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine，pegaspargase,cisplatin,dexamethasone) for patients with stage Ⅲ/Ⅳ Natural Killer (NK)/T Cell Lymphoma.
Detailed description
Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment DDGP (gemcitabine，pegaspargase, cisplatin, dexamethasone) in the patients with stage Ⅲ/Ⅳ NK/T cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDGP regiment | Experimental | Drug: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment |
| SMILE Regiment | Experimental | Drug: Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）Modified SMILE （methotrexate，hexadecadrol，Ifosfamide，L-AsparaginaseL，Etoposide，Mesna）Regiment |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months
- Histological confirmed NK/T cell lymphoma
- None of chemotherapy or radiotherapy has been previously used
- None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups )
- At least one measurable lesion
Key exclusion criteria (12 listed)
- Disagreement on blood sample collection
- Patients allergic of any of drug in this regimen or with metabolic disorder
- Pregnant or lactating women
- Serious medical illness likely to interfere with participation
- Serious infection
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 |
|---|---|---|
| DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)Also: DDGP regimentDDP 20 mg/m2,ivgtt（intravenously guttae）,d1-4;DEX 15mg/m2,ivgtt,d1-5;GEM 800mg/m2,ivgtt,30min,d1,8;Pegasparaginase,im,2500IU/m2 d1.Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles. | Drug | DDGP regiment |
| Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）Also: Modified SMILE regimentMTX,2g/m2 (20% ivgtt（intravenously guttae）,2h;80% ivgtt,4h), d1;DEX,40mg,ivgtt,d2-4;IFO,1.5g/m2,ivgtt,d2-4;L-ASP,6000U/m2,ivgtt,d3-9;VP-16,100mg/m2,ivgtt,d2-4; Mesna,0、4、8h after IFO, 240mg/m2,iv,d2-4.Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles. | Drug | SMILE Regiment |
Primary outcome
Progression-free survival
Time frame: up to end of follow-up-phase (approximately 24 months)
3 secondary outcomes
response rate
Time frame: every 6 weeks,up to completion of treatment(approximately 18 weeks )
overall survival
Time frame: up to the date of death (approximately 5 years)
median survival time
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- Derived from this study: PubMed 35708709Wang X, Zhang L, Liu X, Li X, Li L, Fu X, Sun Z, Wu J, Zhang X, Yan J, Chang Y, Nan F, Zhou Z, Wu X, Tian L, Ma M, Li Z, Yu H, Zhu L, Wang Y, Shi C, Feng X, Li J, Ding M, Zhang J, Dong M, Xue H, Wang J, Zou L, Su L, Wu J, Liu L, Bao H, Zhang L, Guo Y, Guo S, Lu Y, Young KH, Li W, Zhang M. Efficacy and Safety of a Pegasparaginase-Based Chemotherapy Regimen vs an L-asparaginase-Based Chemotherapy Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-Cell Lymphoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1035-1041. doi: 10.1001/jamaoncol.2022.1968.
- Derived from this study: PubMed 31118779Zhao Q, Fan S, Chang Y, Liu X, Li W, Ma Q, Li Y, Wang Y, Zhang L, Zhang M. Clinical efficacy of cisplatin, dexamethasone, gemcitabine and pegaspargase (DDGP) in the initial treatment of advanced stage (stage III-IV) extranodal NK/T-cell lymphoma, and its correlation with Epstein-Barr virus. Cancer Manag Res. 2019 Apr 24;11:3555-3564. doi: 10.2147/CMAR.S191929. eCollection 2019.
- Derived from this study: PubMed 27384676Zhang L, Jia S, Ma Y, Li L, Li X, Wang X, Fu X, Ma W, Qin Y, Li W, Wu J, Sun Z, Zhang X, Nan F, Chang Y, Li Z, Zhang D, Wang G, Yan J, Su L, Wang J, Xue H, Young KH, Zhang M. Efficacy and safety of cisplatin, dexamethasone, gemcitabine and pegaspargase (DDGP) regimen in newly diagnosed, advanced-stage extranodal natural killer/T-cell lymphoma: interim analysis of a phase 4 study NCT01501149. Oncotarget. 2016 Aug 23;7(34):55721-55731. doi: 10.18632/oncotarget.10124.
- Derived from this study: PubMed 27060152Li X, Cui Y, Sun Z, Zhang L, Li L, Wang X, Wu J, Fu X, Ma W, Zhang X, Chang Y, Nan F, Li W, Su L, Wang J, Xue H, Zhang M. DDGP versus SMILE in Newly Diagnosed Advanced Natural Killer/T-Cell Lymphoma: A Randomized Controlled, Multicenter, Open-label Study in China. Clin Cancer Res. 2016 Nov 1;22(21):5223-5228. doi: 10.1158/1078-0432.CCR-16-0153. Epub 2016 Apr 8.
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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.
Mingzhi Zhang, Pro,Dr contact
Mingzhi Zhang, Pro，Dr principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase) and Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna） in people with Nasal and Nasal-type NK/T-cell Lymphoma, run by Mingzhi Zhang 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 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 17 Jul 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Mingzhi Zhang, Pro,Dr (13838565629, mingzhi_zhang@126.com), 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 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 NCT01501149, which also lists 4 linked publications.
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 17 Jul 2015.