Clinical trial NCT01501136: Treatment of Natural Killer/T Cell Lymphoma-I/II
Official title: A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage I/II NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nasal and Nasal-type NK/T-cell Lymphoma
Keywords: NK/T cell lymphoma
chemotherapy
clinical trial
RR
PFS
OS
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Second Hospital of Shanxi Medical University
name: Shanxi Province Cancer Hospital
name: Wuhan University
name: Wuhan TongJi Hospital
name: Wuhan Union Hospital, China
name: Qingdao University
name: Cancer Hospital of Guizhou Province
name: Xinyang Central Hospital
name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
First posted: 2011-12-29
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 I/II NK/T cell lymphoma.

Eligibility 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

Primary outcomes:
measure: Progression-free survival
timeFrame: up to end of follow-up-phase (approximately 24 months)
Secondary outcomes:
measure: Response rate
timeFrame: every 6 weeks,up to completion of treatment(approximately 18 weeks )
measure: overall survival
timeFrame: up to the date of death (approximately 5 years)
measure: median survival time
timeFrame: 5 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Oncology Department of The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Mingzhi Zhang, Pro,Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang L, Wang Y, Li X, Li L, Wang X, Sun Z, Wu J, Fu X, Zhang X, Yu H, Wang G, Chang Y, Yan J, Zhou Z, Wu X, Nan F, Li W, Zhang M. Radiotherapy vs sequential pegaspargase, gemcitabine, cisplatin and dexamethasone and radiotherapy in newly diagnosed early natural killer/T-cell lymphoma: A randomized, controlled, open-label, multicenter study. Int J Cancer. 2021 Mar 15;148(6):1470-1477. doi: 10.1002/ijc.33329. Epub 2020 Oct 19.