Clinical trial NCT02533323: P-Gemox Regimen as First-line Chemotherapy in NK/T Lymphoma Patiens
Official title: Phase 2 Trial of Pegaspargase-Gemox Chemotherapy in Newly Diagnosed, Nasal Type, Extranodal Natural Killer/T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, Extranodal NK-T-Cell
Keywords: NK/T-cell lymphoma
induction chemotherapy
survival
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective study was conducted to evaluate the efficacy and safety profiles of first-line combined gemcitabine, oxaliplatin, and Pegaspargase (P-Gemox) in newly diagnosed, nasal type, extranodal natural killer/T-cell lymphoma.

Detailed description: Treatment P-Gemox dosages were as follows: days 1, 30 min intravenous infusion of 1250 mg/m2 gemcitabine; day 1, 2h intravenous infusion of 85 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2500 U/m2 PEG-ASP at three different sites. The regimen was repeated every 2 weeks for a maximum of six cycles. Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy. Stage IIIE/IVE patients patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Primary tumor radiotherapy was recommended after they achieved CR.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed ENKTL
* age:18-80years
* at lease one measurable lesion
* receive no chemotherapy or radiotherapy before
* Eastern CooperativeOncology Group performance status of 0 to 2.
* Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion Criteria:

* mismatch the inclusion criteria
* systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Primary outcomes:
measure: progression free survival
timeFrame: up to end of follow-up-phase (approximately 3 years)
Secondary outcomes:
measure: complete remission rate
timeFrame: every 4 weeks,up to completion of treatment(approximately 6 months)
measure: overall survival
timeFrame: up to end of follow-up-phase (approximately 3 years)
measure: safety, as measured by adverse events
timeFrame: up to end of follow-up-phase (approximately 3 years)
measure: serum soluble programmed death ligand 1
timeFrame: every 3 weeks,up to completion of treatment(approximately 6 months)
measure: serum interleukin 15
timeFrame: every 3 weeks,up to completion of treatment(approximately 6 months)
measure: Serum ferritin level
timeFrame: every 3 weeks,up to completion of treatment(approximately 6 months)
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Department of Hematological Oncology, Sun Yat-sen University Cancer Center
name: yue lu, MD.
role: PRINCIPAL_INVESTIGATOR
References: