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Treatment of Natural Killer/T Cell Lymphoma-I/II (CTTNKTL-I/II)

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)

VIPD（cisplatin，Etoposide，Ifosfamide， dexamethasone，Mesna）

gemcitabine,pegaspargase,cisplatin,dexamethasone

cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna

Radiotherapy

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 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

sequential trial,DDGP, radiotherapy

sequential trial,VIPD, radiotherapy

sequential trial, radiotherapy,DDGP

sequential trial,radiotherapy, VIPD

Radiotherapy

Arm Description

sequential DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment followed by radiotherapy

sequential VIPD（cisplatin，Etoposide,Ifosfamide,dexamethasone，Mesna） regiment followed by radiotherapy

sequential radiotherapy followed by DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment

sequential radiotherapy followed by VIPD（cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna）regiment chemotherapy

Suitable type intensity-modulated radiation therapy (IMRT) 50GY

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

NCT ID

NCT01501136

First Posted

November 25, 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

1. Study Identification

Unique Protocol Identification Number

NCT01501136

Brief Title

Treatment of Natural Killer/T Cell Lymphoma-I/II

Acronym

CTTNKTL-I/II

Official Title

A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage I/II 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

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 newly diagnosed stage I/II 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 I/II 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

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sequential trial,DDGP, radiotherapy

Arm Type

Experimental

Arm Description

sequential DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment followed by radiotherapy

Arm Title

sequential trial,VIPD, radiotherapy

Arm Type

Experimental

Arm Description

sequential VIPD（cisplatin，Etoposide,Ifosfamide,dexamethasone，Mesna） regiment followed by radiotherapy

Arm Title

sequential trial, radiotherapy,DDGP

Arm Type

Experimental

Arm Description

sequential radiotherapy followed by DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment

Arm Title

sequential trial,radiotherapy, VIPD

Arm Type

Experimental

Arm Description

sequential radiotherapy followed by VIPD（cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna）regiment chemotherapy

Arm Title

Radiotherapy

Arm Type

Experimental

Arm Description

Suitable type intensity-modulated radiation therapy (IMRT) 50GY

Intervention Type

Other

Intervention Name(s)

DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)

Other Intervention Name(s)

DDGP, chemotherapy, radiotherapy

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. Completion of chemotherapy is followed by radiotherapy 50Gy.Efficacy was evaluated every two cycles.

Intervention Type

Other

Intervention Name(s)

VIPD（cisplatin，Etoposide，Ifosfamide， dexamethasone，Mesna）

Other Intervention Name(s)

VIPD, chemotherapy, radiotherapy

Intervention Description

DDP,33mg/m2,ivgtt（intravenously guttae）,d1-3；VP-16,100mg/m2,ivgtt,d1-3；IFO,1.2g/m2,ivgtt,d1-3；DEX,40mg,ivgtt,d1-4；Mesna,0、4、8h after IFO,240mg/m2,iv,d1-3.Every 21 days for one cycle and three cycles are required. Completion of chemotherapy is followed by radiotherapy 50Gy.Efficacy was evaluated every two cycles.

Intervention Type

Other

Intervention Name(s)

gemcitabine,pegaspargase,cisplatin,dexamethasone

Other Intervention Name(s)

radiotherapy, chemotherapy, DDGP

Intervention Description

Radiotherapy 50Gy is followed by chemotherapy(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

Other

Intervention Name(s)

cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna

Other Intervention Name(s)

radiotherapy, chemotherapy, VIPD

Intervention Description

Radiotherapy 50Gy is followed by chemotherapy(DDP,33mg/m2,ivgtt（intravenously guttae）,d1-3；VP-16,100mg/m2,ivgtt,d1-3；IFO,1.2g/m2,ivgtt,d1-3；DEX,40mg,ivgtt,d1-4；Mesna,0、4、8h after IFO,240mg/m2,iv,d1-3.Every 21 days for one cycle and three cycles are required ).Efficacy was evaluated every two cycles.

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

Suitable type intensity-modulated radiation therapy(IMRT)50Gy

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

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

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

Phone

13838565629

mingzhi_zhang@126.com

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Dr

12. IPD Sharing Statement

Citations:

PubMed Identifier

33034052

Citation

Zhang L, Wang Y, Li X, Li L, Wang X, Sun Z, Wu J, Fu X, Zhang X, Yu H, Wang G, Chang Y, Yan J, Zhou Z, Wu X, Nan F, Li W, Zhang M. Radiotherapy vs sequential pegaspargase, gemcitabine, cisplatin and dexamethasone and radiotherapy in newly diagnosed early natural killer/T-cell lymphoma: A randomized, controlled, open-label, multicenter study. Int J Cancer. 2021 Mar 15;148(6):1470-1477. doi: 10.1002/ijc.33329. Epub 2020 Oct 19.

Results Reference

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Treatment of Natural Killer/T Cell Lymphoma-I/II

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