Trial | NCT01501149  Report issue

Title

Treatment of Natural Killer/T Cell Lymphoma-Ⅲ/Ⅳ
A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage Ⅲ/Ⅳ NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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.
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 Started
Jan 31
2011
Primary Completion
Dec 31
2015
Anticipated
Study Completion
May 31
2019
Anticipated
Last Update
Jul 17
2015
Estimate

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 names: DDGP 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 names: Modified SMILE regiment

DDGP regiment Experimental

DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment

SMILE Regiment Experimental

Modified SMILE （methotrexate，hexadecadrol，Ifosfamide，L-AsparaginaseL，Etoposide，Mesna）Regiment

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
No Results Posted