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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Extranodal NK/T-cell Lymphoma
• Intervention / Treatment: Combination product: Pegaspargase combined with concurrent radiotherapy.

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hua Wang, MD; Phone Number: 15920352412; Email: wanghua@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • HuaWang
      • Contact: Hua Wang, MD; Phone Number: 15920352412; Email: wagnhua@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients diagnosed with early ENKTL.; Patients received 4 cycles of pegaspargase including CCRT ( involved field radiotherapy 50GY, concurrent 2 cycles of pegaspargase treatment ).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression free survival (PFS) rate	From enrollment to the end of treatment at 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	two-year overall survival rate	From enrollment to the end of treatment at 2 years
CRR	complete response rate	From enrollment to the end of treatment at 2 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Hua Wang, MD, Sun Yat-senU

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: extranodal NK/T-cell lymphoma; concurrent chemoradiotherapy; pegaspargase
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell; Antineoplastic Agents; Pegaspargase
• Other Study ID Numbers: B2018-053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No