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

NCT02705508 | Unknown Phase 2

• 1 other identifier: NK-SYSUCC-2016
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Refusal

Keywords

extranodal natural killer/T-cell lymphoma; nasal type; chemotherapy; radiotherapy

Outcome Measures

Primary Outcomes (1)

• progression free survival

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

Secondary Outcomes (2)

• 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 Outcomes (1)

• 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)

Study Arms (1)

PEG group

EXPERIMENTAL

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; Drug: etoposide; Drug: Pegaspargase; Radiation: involved-field radiotherapy

Interventions

Gemcitabine DRUG

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

Also known as: Gemzar

PEG group

etoposide DRUG

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

Also known as: Etoposide phosphate

PEG group

Pegaspargase DRUG

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

Also known as: Oncaspar

PEG group

involved-field radiotherapy 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.

Also known as: IFRT

PEG group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• China Food and Drug Administration: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Please Select, 510060, China

RECRUITING

Related Publications (1)

• Feng D, Yan Z, Fu B, Bai S, Zhu L, Gale RP, Xia Z, Liang Y, Wang H. Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma. Hematology. 2024 Dec;29(1):2402102. doi: 10.1080/16078454.2024.2402102. Epub 2024 Sep 13.

  PMID: 39268981 DERIVED

MeSH Terms

Conditions

Treatment Refusal

Interventions

Gemcitabine; Etoposide; etoposide phosphate; pegaspargase

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• hua wang, MD.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hua wang, MD.

CONTACT

0086-02087342462; wanghua@sysucc.org.cn

hua wang, MD.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 10, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)