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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PEG-ASP+Gemox Regimen and Thalidomide for NK/T Lymphoma

NCT02085655

Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type

UNKNOWN PHASE3

Safety & Efficacy of Peg-ASP-based CCRT in Early Stage ENKTL

NCT06406556

Extranodal NK/T-cell Lymphoma

RECRUITING PHASE2

Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Extra-nodal NK/T Cell Lymphoma

NCT04484506

NK/T Cell Lymphoma Nos

RECRUITING PHASE2

Efficacy and Safety Study of P-Gemox vs.EPOCH as First-line Chemotherapy to Treat NK/T-cell Lymphoma With Early Stage

NCT02359162

Lymphoma, Extranodal NK-T-Cell

TERMINATED PHASE3

MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma

NCT02631239

Extranodal NK/T-cell Lymphoma, Nasal Type

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Treatment Refusal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

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

etoposide

Intervention Type DRUG

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

Pegaspargase

Intervention Type DRUG

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

involved-field radiotherapy

Intervention Type RADIATION

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gemcitabine

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

Intervention Type DRUG

etoposide

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

Intervention Type DRUG

Pegaspargase

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

Intervention Type DRUG

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.

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Gemzar Etoposide phosphate Oncaspar IFRT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.