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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02705508

Collaborator

China Food and Drug Administration (Other)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Treatment Refusal	Drug: Gemcitabine Drug: etoposide Drug: Pegaspargase Radiation: involved-field radiotherapy	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Trial of PEG-ASP Combined With Etoposide and Gemcitabine (PEG) as First-line Chemotherapy to Treat NK/T-cell Lymphoma

Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEG group 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 2500U/m2 Pegaspargase 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 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 were given for a maximum of six cycles.	Drug: Gemcitabine 1000mg/m2, ivd on day 1 and 8 of each 21 day cycle. Other Names: Gemzar Drug: etoposide 100mg/m2，4h-intravenous infusion on day1-3 of each 21 day cycle. Other Names: Etoposide phosphate Drug: Pegaspargase 2500U/m2 im on day 1 of each 21 day cycle. Other Names: Oncaspar Radiation: involved-field radiotherapy 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. Other Names: IFRT

Arm

Intervention/Treatment

Experimental: PEG group

Drug: Gemcitabine

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

Other Names:

Gemzar

Drug: etoposide

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

Other Names:

Etoposide phosphate

Drug: Pegaspargase

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

Other Names:

Oncaspar

Radiation: involved-field radiotherapy

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.

Other Names:

IFRT

Outcome Measures

Primary Outcome Measures

progression free survival [up to end of follow-up-phase (approximately 3 years)]

Secondary Outcome Measures

overall survival [up to end of follow-up-phase (approximately 3 years)]
complete remission rate [every 3 weeks,up to completion of chemotherapy(approximately 3months)]

Other Outcome Measures

Incidence of Treatment-Emergent Adverse Events classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) [up to end of follow-up-phase (approximately 3 years)]
including hematological safety and non-hematological safety

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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