Avelumab in Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma[AVENT STUDY]

Phase 2

• Conditions: Lymphoma, Extranodal NK-T-Cell
• Interventions: Drug: avelumab

• Registration Number: NCT03439501
• Lead Sponsor: Samsung Medical Center

Brief Summary

This study was conducted to evaluate the complete response rate of avelumab in patients with NK / T-cell lymphoma besides relapsed or refractory stage lymphoma.

Detailed Description

Extranodal natural killer/T-cell lymphoma (ENKTL) generally has poorer prognosis than other lymphomas because the majority of patients are present as advanced disease and show poor response to treatment.

In particular, treatment of relapsed or refractory stage ENKTL is very poor and there is no standard treatment.

ENKTL is entirely infected with Epstein-Barr virus (EBV) and the prevalence of this disease is closely related to EBV.

Therefore, the biological properties of ENKTL may be affected by EBV-related protein and LMP1 may induce activation of molecules in various sub-channels, such as PI3K/Akt and NF-kB, and affect the aggressiveness of lymphoma.

As an increase in PDL1 has been reported recently among the major roles of LMP1, the role of Immuno-oncology drug targeting PDL1 among ENKTL is expected.

Therefore, Avelumab that inhibits PDL1 may effectively treat NK/T-cell lymphoma besides relapsed or refractory stage lymphoma.

Study Timeline

• Study Start: 2018-01-16
• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-24
• Primary Completion: 2022-01-30
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
avelumab	avelumab	* 1 Cycle: 10mg/kg Avelumab administered via IV every 2 weeks (1st, 15th) * Interval of 1 cycle: 28 days ③ Administration schedule: Repeated until disease progression or unacceptable toxicity and dose adjustments may be permitted based on the toxicity that occurs every cycle.

Primary Outcome Measures

Name	Time	Method
The rate of response of avelumab.	From date of enrollment until the date first documented disease progression or unacceptable toxicity, whichever came first, assessed up to 48 months	To assess the efficacy of disease control including complete response (CR), partial response (PR) and stable disease (SD)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	the time between the date of treatment start and the date of death due to any cause or date of disease progression..assessed up to 48 months	It is a measure of the period of survival without disease progression
Toxicity Profile	from the date of informed consent signature to 30 days after last drug administration.	Clinical and laboratory toxicity/symptomatology will be graded based on the NCIC CTG v4.03. Adverse events not reported in NCIC CTG will be categorized into mild, moderate, severe, and fatal and further classified to CTCAE Grades 1-4.
Overall survival (OS)	Time between the start of treatment and the date of death.assessed up to 48 months	It measures the time from start of treatment to death.

Trial Locations

Locations (1)

81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea; 🇰🇷 Seoul, Korea, Republic of