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

This study is currently recruiting participants.
Verified January 2012 by Zhengzhou University
Sponsor:
Collaborators:
The Second Hospital of Shanxi Medical University
Cancer hospital of shanxi province
Wuhan University
Wuhan TongJi Hospital
Wuhan Union Hospital, China
Qingdao Medical University Hospital
Cancer Hospital of Guizhou Province
Central Hospital Of Xinxiang
The First Affiliated Hospital of He'nan University of Science and Technology
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University
ClinicalTrials.gov Identifier:
NCT01501149
First received: November 29, 2011
Last updated: January 1, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Nasal and Nasal-type NK/T-cell Lymphoma
 Drug: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)
Drug: Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Zhengzhou University:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: up to end of follow-up-phase (approximately 24 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate [ Time Frame: every 6 weeks,up to completion of treatment(approximately 18 weeks ) ] [ Designated as safety issue: No ]
    21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles.

  • overall survival [ Time Frame: up to the date of death (approximately 5 years) ] [ Designated as safety issue: No ]
  • median survival time [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DDGP regiment
DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment
 Drug: 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. Efficacy was evaluated every two cycles.
Other Name: DDGP regiment
Experimental: SMILE Regiment
Modified SMILE （methotrexate，hexadecadrol，Ifosfamide，L-AsparaginaseL，Etoposide，Mesna）Regiment
 Drug: Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）
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.
Other Name: Modified SMILE regiment

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.

  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501149

Contacts
Contact: Mingzhi Zhang, Pro,Dr 13838565629 mingzhi_zhang@126.com
Contact: Mingzhi Zhang, Pro,Dr mingzhi_zhang@126.com

Locations
China, Henan
Oncology Department of The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Mingzhi Zhang, Pro,Dr         mingzhi_zhang@126.com    
Principal Investigator: Mingzhi Zhang, Pro,Dr            
Sponsors and Collaborators
Mingzhi Zhang
The Second Hospital of Shanxi Medical University
Cancer hospital of shanxi province
Wuhan University
Wuhan TongJi Hospital
Wuhan Union Hospital, China
Qingdao Medical University Hospital
Cancer Hospital of Guizhou Province
Central Hospital Of Xinxiang
The First Affiliated Hospital of He'nan University of Science and Technology
Investigators
Principal Investigator: Mingzhi Zhang, Pro，Dr The First Affiliated Hospital of Zhengzhou University
  More Information

No publications provided

Responsible Party: Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University
ClinicalTrials.gov Identifier: NCT01501149     History of Changes
Other Study ID Numbers: hnslblzlzx2011-2
Study First Received: November 29, 2011
Last Updated: January 1, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Zhengzhou University:
NK/T cell lymphoma
chemotherapy
clinical trial
 RR
PFS
OS

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Mesna
Gemcitabine
Pegaspargase
Cisplatin
Dexamethasone
Etoposide
 Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013