Treatment of Natural Killer/T Cell Lymphoma-Ⅲ/Ⅳ (CTTNKTL-Ⅲ/Ⅳ)
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|ClinicalTrials.gov Identifier: NCT01501149|
Recruitment Status : Unknown
Verified July 2015 by Mingzhi Zhang, Zhengzhou University.
Recruitment status was: Recruiting
First Posted : December 29, 2011
Last Update Posted : July 17, 2015
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: DDGP regiment
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
- Progression-free survival [ Time Frame: up to end of follow-up-phase (approximately 24 months) ]
- 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.
- overall survival [ Time Frame: up to the date of death (approximately 5 years) ]
- median survival time [ Time Frame: 24 months ]
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
|Contact: Mingzhi Zhang, Pro,Dremail@example.com|
|Contact: Mingzhi Zhang, Pro,Drfirstname.lastname@example.org|
|Oncology Department of The First Affiliated Hospital of Zhengzhou University||Recruiting|
|Zhengzhou, Henan, China, 450052|
|Contact: Mingzhi Zhang, Pro,Dr email@example.com|
|Principal Investigator: Mingzhi Zhang, Pro,Dr|
|Principal Investigator:||Mingzhi Zhang, Pro，Dr||The First Affiliated Hospital of Zhengzhou University|