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

July 15, 2015 updated by: Mingzhi Zhang

A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage I/II 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 newly diagnosed stage I/II Natural Killer (NK)/T Cell Lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Oncology Department of The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Mingzhi Zhang, Pro,Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sequential trial,DDGP, radiotherapy
sequential DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment followed by radiotherapy
Other: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)
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.
Other Names:
  • radiotherapy
  • chemotherapy
  • DDGP
Experimental: sequential trial,VIPD, radiotherapy
sequential VIPD（cisplatin，Etoposide,Ifosfamide,dexamethasone，Mesna） regiment followed by radiotherapy
Other: VIPD（cisplatin，Etoposide，Ifosfamide， dexamethasone，Mesna）
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.
Other Names:
  • radiotherapy
  • chemotherapy
  • VIPD
Experimental: sequential trial, radiotherapy,DDGP
sequential radiotherapy followed by DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment
Other: gemcitabine,pegaspargase,cisplatin,dexamethasone
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.
Other Names:
  • radiotherapy
  • chemotherapy
  • DDGP
Experimental: sequential trial,radiotherapy, VIPD
sequential radiotherapy followed by VIPD（cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna）regiment chemotherapy
Other: cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna
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.
Other Names:
  • radiotherapy
  • chemotherapy
  • VIPD
Experimental: Radiotherapy
Suitable type intensity-modulated radiation therapy (IMRT) 50GY
Radiation: Radiotherapy
Suitable type intensity-modulated radiation therapy(IMRT)50Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: up to end of follow-up-phase (approximately 24 months)
up to end of follow-up-phase (approximately 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: up to the date of death (approximately 5 years)
up to the date of death (approximately 5 years)
Response rate
Time Frame: every 6 weeks,up to completion of treatment(approximately 18 weeks )
21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles.
every 6 weeks,up to completion of treatment(approximately 18 weeks )
median survival time
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mingzhi Zhang

Collaborators

Shanxi Province Cancer Hospital
Wuhan University
Qingdao University
Wuhan Union Hospital, China
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Wuhan TongJi Hospital
Second Hospital of Shanxi Medical University
Xinyang Central Hospital
Cancer Hospital of Guizhou Province

Investigators

  • Principal Investigator: Mingzhi Zhang, Pro,Dr, the First Affiliated Hospital of Zhengzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

November 25, 2011

First Submitted That Met QC Criteria

December 25, 2011

First Posted (Estimate)

December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hnslblzlzx2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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