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

Extranodal NK/T-cell Lymphoma Clinical Trial

— ENKTL  

Official title:

Evaluate the Safety and Efficacy of Pegaspargase-based Concurrent Chemoradiotherapy in the Treatment of Early Stage Extranodal NK/T Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406556
• Other study ID #: B2018-053
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2016
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2024
• Source: Sun Yat-sen University
• Contact: Hua Wang, MD
• Phone: 15920352412
• Email: wanghua[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of concurrent chemoradiotherapy by using single-drug pegaspargase for patients with ENKTL in stage IE to IIE.

Description:

The treatment regimen included CCRT ( involved field radiotherapy 50GY, concurrent 2 cycles of pegaspargase treatment ) followed by 4 cycles of pegaspargase. Chemotherapy and RT were performed simultaneously within one week after enrollment. The administration regimen was as follows : day1, deep intramuscular injection of 2500 unit/m2 pegaspargase at three different sites, and repeated once every 3 weeks. 3D conformal radiotherapy was performed using 4 or 6 MV photons generated by a linear accelerator. The radiation dose was 50 Gy, 2.0 Gy / time, 1 time / d, for 5 weeks. The clinical target volume ( CTV ) of limited stage IE patients was defined as bilateral nasal cavity, bilateral ethmoid sinus and ipsilateral maxillary sinus. The CTV of extensive stage IE patients was extended to the affected tissues. The CTV of stage IIE lesions also included the involved cervical lymph node area.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1.The patient was pathologically diagnosed as ENKTL and had not received any previous treatment for ENKTL;2.The estimated survival time = 3 months. 3.18-75 years old ; 4. Ann-Arbor stage was IE-IIE ; 5. ECOG performance status 0-2 ; 6.Clinicians judged that patients were suitable for concurrent chemoradiotherapy ; 7.No radiotherapy or hormone drugs were received within 4 weeks before treatment;8.After the patients were enrolled in the trial, they could not accept other drugs that may have therapeutic effects on ENKTL ; 9.WBC= 3 × 109 / L, NE = 1.5 × 109 / L, PLT = 100 × 109 / L ; 10.Serum creatinine = 1.5mg / dL, creatinine clearance rate = 50mL / min ; 11.ALT, AST = 3 × ULN ( normal upper limit ) ; total bilirubin = 2 × ULN ; 12.Serum fibrinogen level = 1.0g / L ; 13.Signed informed consent form.

Exclusion Criteria:1.Symptomatic CNS involvement, previous or current accompanied by other malignant tumors ; 2.The primary lesion is ENKTL from non-upper respiratory gastrointestinal tract ; 3.Patients with poor general condition, ECOG performance status >2 ; 4.Women in pregnancy or lactation; 5.The patient ( male or female ) has the possibility of fertility but is unwilling or does not take effective contraceptive measures; 6. Known allergies to test drugs or any excipient component of these products ;7.Doctors believe that patients are not suitable for concurrent chemoradiotherapy; 8.Active infection ( determined by the researcher ) ; 9.According to the researchers ' judgment, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study;10. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral

Intervention

Combination Product:
• Pegaspargase combined with concurrent radiotherapy.
Patients receive CCRT (radiation 50 Gy and two cycles of pegaspargase 2500 unit/m2 every 3 weeks). 4 courses of pegaspargase were performed after CCRT.

Locations

Country	Name	City	State
China	HuaWang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progression free survival (PFS) rate	From enrollment to the end of treatment at 2 years
Secondary	OS	two-year overall survival rate	From enrollment to the end of treatment at 2 years
Secondary	CRR	complete response rate	From enrollment to the end of treatment at 2 weeks