Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL

NCT04676789 | Unknown Phase 2

• 1 other identifier: SYSUCC-ENKTL-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the trial is to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma.All eligible patients will be treated with sintilimab combined with pegaspargase administered every 3 weeks for 4 cycles followed by standard radiotherapy with or without concurrent sintilimab and pegaspargase administered every 3 weeks. After radiotherapy, patients with complete remission with positive plasma EBV-DNA or partial response will continue with sintilimab maintenance up to 2 years.

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Keywords

sintilimab; Pegaspargase; Definitive intensity-modulated radiotherapy (IMRT)

Outcome Measures

Primary Outcomes (1)

• progression free survival (PFS)

  Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy, or death from any cause, whichever occurred first.

  Baseline up to data cut-off (up to approximately 4 years)

Secondary Outcomes (6)

• complete remission (CR) rate

  At the end of Cycle 6 (each cycle is 21 days)

• overall response rate (ORR)

  At the end of Cycle 6 (each cycle is 21 days)

• overall survival (OS)

  Baseline up to data cut-off (up to approximately 4 years)

• Duration of response

  Baseline up to data cut-off (up to approximately 4 years)

• EBV-DNA load change

  At the end of Cycle 6 (each cycle is 21 days)

Study Arms (1)

Intervention/treatment

EXPERIMENTAL

Patients will receive sintilimab,200mg,ivdrip,day1; pegaspargase,2,500 unit/m2 deep intramuscular injection at three different sites,day 1, every 3 weeks for 4 cycles before radiation.Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent sintilimab of 200mg and pegaspargase,2,500 unit/m2 will be administered every 3 weeks for 2 cycles during IMRT for patients who do not achieve complete remission to previous induction therapy. After radiotherapy or CCRT, patients achieving CR with positive plasma EBV-DNA or partial response will continue with sintilimab maintenance up to 2 years.

Drug: Pegaspargase; Drug: Anti-PD-1 monoclonal antibody; Radiation: Definitive intensity-modulated radiotherapy (IMRT)

Interventions

Pegaspargase DRUG

Pegaspargase 2500IU/m2 administered by intramuscular injection on Day 1

Also known as: P-ASP

Intervention/treatment

Anti-PD-1 monoclonal antibody DRUG

Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 1

Also known as: sintilimab

Intervention/treatment

Definitive intensity-modulated radiotherapy (IMRT) RADIATION

Definitive intensity-modulated radiotherapy (IMRT) of 50 Gy will be given in 25 days

Also known as: IMRT

Intervention/treatment

Eligibility Criteria

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

You may qualify if:

• newly diagnosed ENKTL
• age:18-80years
• Ann Arbor stage IE,or stage IIE
• at lease one measurable lesion
• receive no chemotherapy or radiotherapy before
• Eastern CooperativeOncology Group performance status of 0 to 2.
• Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

You may not qualify if:

• non-nasal type disease
• systematic central nervous system involvement
• previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Please Select, 510060, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

pegaspargase; spartalizumab; sintilimab

Condition Hierarchy (Ancestors)

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

Study Officials

• Hua Wang, MD.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Wang, MD.

CONTACT

0086-20-87342462; 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: professor

Model Details: treatment with sintilimab and pegaspargase combined with intensity-modulated radiotherapy (IMRT)

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: September 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 31, 2024
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

CN (1)