PEG-ASP, Etoposide and Gemcitabine for Natural Killer/T Lymphoma

Sun Yat-sen University35 enrolled

Overview

Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the efficacy and safety of pegylated aspargase(PEG-ASP)combined with etoposide and gemcitabine (PEG) treatment in this population.

Treatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500unit/m2 PEG-ASP at three different sites.The regimen was repeated every 3 weeks.Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got complete remission ,partial regression or stable disease.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 were given for a maximum of six cycles.Refractory/relapsed patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Autologous haematopoietic stem cell transplantation (AHSCT) was recommended after achieving CR for advanced stage and refractory/relapsed patients

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Treatment Refusal

Interventions

GemcitabineDRUG

1000mg/m2, ivd on day 1 and 8 of each 21 day cycle.

etoposideDRUG

100mg/m2，4h-intravenous infusion on day1-3 of each 21 day cycle.

PegaspargaseDRUG

2500U/m2 im on day 1 of each 21 day cycle.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification; 2. age≥18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 4. at least one measurable lesion; 5. adequate haematologic function (haemoglobin \> 9.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l), 6. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), 7. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); 8. normal coagulation function and electrocardiogram results. 9. Prior chemotherapy and radiotherapy should have been completed \>4 weeks 10.earlier,willingness to provide written informed consent. Exclusion Criteria: \-

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Please Select, China

RECRUITING

Outcomes

Primary Outcomes

progression free survival

Time frame: up to end of follow-up-phase (approximately 3 years)

Secondary Outcomes

overall survival

Time frame: up to end of follow-up-phase (approximately 3 years)

complete remission rate

Time frame: every 3 weeks,up to completion of chemotherapy(approximately 3months)

Central Contacts

hua wang, MD.

CONTACT

0086-02087342462 wanghua@sysucc.org.cn

hua wang, MD.

CONTACT

Data from ClinicalTrials.gov

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