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

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ClinicalTrials.gov Identifier: NCT01501149
Recruitment Status : Recruiting
First Posted : December 29, 2011
Last Update Posted : July 17, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment 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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : January 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : May 2019


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to end of follow-up-phase (approximately 24 months) ]

Secondary Outcome Measures :
  1. 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.

  2. overall survival [ Time Frame: up to the date of death (approximately 5 years) ]
  3. median survival time [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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
Investigators
Principal Investigator: Mingzhi Zhang, Pro,Dr The First Affiliated Hospital of Zhengzhou University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015

Keywords provided by Mingzhi Zhang, 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
Gemcitabine
Etoposide phosphate
Pegaspargase
Cisplatin
Dexamethasone
Etoposide
Asparaginase
Dexamethasone acetate
BB 1101
Mesna
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal