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

Treatment Refusal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02705508
• Other study ID #: NK-SYSUCC-2016
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: Sun Yat-sen University
• Contact: hua wang, MD.
• Phone: 0086-02087342462
• Email: wanghua[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Lymphoma
• Treatment Refusal

Intervention

Drug:
• Gemcitabine
1000mg/m2, ivd on day 1 and 8 of each 21 day cycle.
• etoposide
100mg/m2,4h-intravenous infusion on day1-3 of each 21 day cycle.
• Pegaspargase
2500U/m2 im on day 1 of each 21 day cycle.

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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	China Food and Drug Administration

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)	including hematological safety and non-hematological safety	up to end of follow-up-phase (approximately 3 years)
Primary	progression free survival		up to end of follow-up-phase (approximately 3 years)
Secondary	overall survival		up to end of follow-up-phase (approximately 3 years)
Secondary	complete remission rate		every 3 weeks,up to completion of chemotherapy(approximately 3months)