Lymphoma, Extranodal NK-T-Cell
Conditions
Keywords
NK/T-cell lymphoma, induction chemotherapy, survival
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.
Interventions
DRUGgemcitabine
gemcitabine :1250mg/m2 (ivdrip) on days 1
DRUGoxaliplatin
oxaliplatin :85 mg/m2 (ivdrip) on day 1
DRUGpegaspargase
pegaspargase : 2500 IU/m2 (intramuscular injection)
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | up to end of follow-up-phase (approximately 3 years) | time from the date of enrollment to date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | up to end of follow-up-phase (approximately 3 years) | overall survival (OS): time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first |
| safety, as measured by adverse events | up to end of follow-up-phase (approximately 3 years) | ncluding hematological safety and non-hematological safety.All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) |
| complete remission rate | every 4 weeks,up to completion of treatment(approximately 6 months) | The criteria for the efficacy evaluation (overall response rate and complete remission) of the regimen is according to the following article: Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999;17:1244. |
| serum interleukin 15 | every 3 weeks,up to completion of treatment(approximately 6 months) | serum interleukin 15 is measured using an enzyme-linked immunosorbent assay |
| Serum ferritin level | every 3 weeks,up to completion of treatment(approximately 6 months) | Serum ferritin level is measured using radioimmunoassay |
| serum soluble programmed death ligand 1 | every 3 weeks,up to completion of treatment(approximately 6 months) | Soluble PD-L1 is measured using an enzyme-linked immunosorbent assay |
Countries
China
Outcome results
None listed