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

NCT06406556 | Recruiting Phase 2

• 1 other identifier: B2018-053
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extranodal NK/T-cell Lymphoma

Keywords

extranodal NK/T-cell lymphoma; concurrent chemoradiotherapy; pegaspargase

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival (PFS) rate

  From enrollment to the end of treatment at 2 years

Secondary Outcomes (2)

• OS

  From enrollment to the end of treatment at 2 years

• CRR

  From enrollment to the end of treatment at 2 weeks

Study Arms (1)

Patients diagnosed with early ENKTL.

EXPERIMENTAL

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.

Interventions

Pegaspargase combined with concurrent radiotherapy. COMBINATION_PRODUCT

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.

Patients diagnosed with early ENKTL.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

HuaWang

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Hua Wang, MD

  Sun Yat-senU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Wang, MD

CONTACT

15920352412; wanghua@sysucc.org.cn

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: Associate senior doctor

Model Details: Patients receive CCRT (radiation 50 Gy and two cycles of pegaspargase 2500 unit/m2 every 3 weeks) followed by 4 courses of pegaspargase.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: March 1, 2016
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)