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Treatment of Natural Killer/T Cell Lymphoma-Ⅲ/Ⅳ (CTTNKTL-Ⅲ/Ⅳ)

Primary Purpose

Nasal and Nasal-type NK/T-cell Lymphoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)
Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）
Sponsored by
Mingzhi Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal and Nasal-type NK/T-cell Lymphoma focused on measuring NK/T cell lymphoma, chemotherapy, clinical trial, RR, PFS, OS

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Oncology Department of The First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DDGP regiment

SMILE Regiment

Arm Description

DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment

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

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

response rate
21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles.
overall survival
median survival time

Full Information

First Posted
November 29, 2011
Last Updated
July 15, 2015
Sponsor
Mingzhi Zhang
Collaborators
Second Hospital of Shanxi Medical University, Shanxi Province Cancer Hospital, Wuhan University, Wuhan TongJi Hospital, Wuhan Union Hospital, China, Qingdao University, Cancer Hospital of Guizhou Province, Xinyang Central Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01501149
Brief Title
Treatment of Natural Killer/T Cell Lymphoma-Ⅲ/Ⅳ
Acronym
CTTNKTL-Ⅲ/Ⅳ
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mingzhi Zhang
Collaborators
Second Hospital of Shanxi Medical University, Shanxi Province Cancer Hospital, Wuhan University, Wuhan TongJi Hospital, Wuhan Union Hospital, China, Qingdao University, Cancer Hospital of Guizhou Province, Xinyang Central Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal and Nasal-type NK/T-cell Lymphoma
Keywords
NK/T cell lymphoma, chemotherapy, clinical trial, RR, PFS, OS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DDGP regiment
Arm Type
Experimental
Arm Description
DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment
Arm Title
SMILE Regiment
Arm Type
Experimental
Arm Description
Modified SMILE （methotrexate，hexadecadrol，Ifosfamide，L-AsparaginaseL，Etoposide，Mesna）Regiment
Intervention Type
Drug
Intervention Name(s)
DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)
Other Intervention Name(s)
DDGP regiment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）
Other Intervention Name(s)
Modified SMILE regiment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
up to end of follow-up-phase (approximately 24 months)
Secondary Outcome Measure Information:
Title
response rate
Description
21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles.
Time Frame
every 6 weeks,up to completion of treatment(approximately 18 weeks )
Title
overall survival
Time Frame
up to the date of death (approximately 5 years)
Title
median survival time
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingzhi Zhang, Pro,Dr
Phone
13838565629
Email
mingzhi_zhang@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mingzhi Zhang, Pro,Dr
Email
mingzhi_zhang@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingzhi Zhang, Pro，Dr
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Department of The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingzhi Zhang, Pro,Dr
Email
mingzhi_zhang@126.com
First Name & Middle Initial & Last Name & Degree
Mingzhi Zhang, Pro,Dr

12. IPD Sharing Statement

Citations:
PubMed Identifier
35708709
Citation
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.
Results Reference
derived
PubMed Identifier
31118779
Citation
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.
Results Reference
derived
PubMed Identifier
27060152
Citation
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.
Results Reference
derived
PubMed Identifier
27384676
Citation
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.
Results Reference
derived

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Treatment of Natural Killer/T Cell Lymphoma-Ⅲ/Ⅳ

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