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

Mingzhi Zhang

Status and phase: Unknown; Phase 4

Conditions: Nasal and Nasal-type NK/T-cell Lymphoma

Treatments: Other: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase); Other: VIPD（cisplatin，Etoposide，Ifosfamide， dexamethasone，Mesna）; Other: cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna; Other: gemcitabine,pegaspargase,cisplatin,dexamethasone; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01501136

hnslblzlzx2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 5 patient groups

sequential trial,DDGP, radiotherapy

Experimental group

Description:

sequential DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment followed by radiotherapy

Treatment:

Other: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)

sequential trial,VIPD, radiotherapy

Experimental group

Description:

sequential VIPD（cisplatin，Etoposide,Ifosfamide,dexamethasone，Mesna） regiment followed by radiotherapy

Treatment:

Other: VIPD（cisplatin，Etoposide，Ifosfamide， dexamethasone，Mesna）

sequential trial, radiotherapy,DDGP

Experimental group

Description:

sequential radiotherapy followed by DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment

Treatment:

Other: gemcitabine,pegaspargase,cisplatin,dexamethasone

sequential trial,radiotherapy, VIPD

Experimental group

Description:

sequential radiotherapy followed by VIPD（cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna）regiment chemotherapy

Treatment:

Other: cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna

Radiotherapy

Experimental group

Description:

Suitable type intensity-modulated radiation therapy (IMRT) 50GY

Treatment:

Radiation: Radiotherapy