Avelumab in Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma[AVENT STUDY]
|ClinicalTrials.gov Identifier: NCT03439501|
Recruitment Status : Active, not recruiting
First Posted : February 20, 2018
Last Update Posted : January 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Extranodal NK-T-Cell||Drug: avelumab||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Avelumab in Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma|
|Actual Study Start Date :||January 16, 2018|
|Estimated Primary Completion Date :||April 24, 2021|
|Estimated Study Completion Date :||September 30, 2021|
- The rate of response of avelumab. [ Time Frame: 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)
- Progression-free survival [ Time Frame: 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
- Overall survival (OS) [ Time Frame: 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.
- Toxicity Profile [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439501
|Korea, Republic of|
|81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea|
|Seoul, Korea, Republic of, 06351|
|Principal Investigator:||Wonseog Kim, M.D||Samsung Medical Center|