NCT01501149

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

4.9 years

First QC Date

November 29, 2011

Last Update Submit

July 15, 2015

Conditions

Nasal and Nasal-type NK/T-cell Lymphoma

Keywords

NK/T cell lymphomachemotherapyclinical trialRRPFSOS

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    up to end of follow-up-phase (approximately 24 months)

Secondary Outcomes (3)

  • response rate

    every 6 weeks,up to completion of treatment(approximately 18 weeks )

  • overall survival

    up to the date of death (approximately 5 years)

  • median survival time

    24 months

Study Arms (2)

DDGP regiment

EXPERIMENTAL

DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment

Drug: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)

SMILE Regiment

EXPERIMENTAL

Modified SMILE （methotrexate，hexadecadrol，Ifosfamide，L-AsparaginaseL，Etoposide，Mesna）Regiment

Drug: Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）

Interventions

DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)DRUG

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.

Also known as: DDGP regiment
DDGP regiment
Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）DRUG

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.

Also known as: Modified SMILE regiment
SMILE Regiment

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • At least one measurable lesion
  • None of other serious diseases, cardiopulmonary function is normal
  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 35708709DERIVED

  • Zhao 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.

    PMID: 31118779DERIVED

  • Zhang 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.

    PMID: 27384676DERIVED

  • Li 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.

    PMID: 27060152DERIVED

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Mingzhi Zhang, Pro，Dr

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingzhi Zhang, Pro,Dr

CONTACT

13838565629mingzhi_zhang@126.com

Mingzhi Zhang, Pro,Dr

CONTACT

mingzhi_zhang@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
the director of oncology department of the first affiliated hospital

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 29, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2015

Study Completion

May 1, 2019

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

CN(1)