ENKTL is a highly aggressive NHL with a higher incidence in Asia. L-asparaginase containing chemotherapy regimens are the standard first-line treatment with apparently toxicities. In 2020 ASH, the investigators reported Sintilimab(anti-PD-1 antibody) plus Chidamide(an oral subtype-selective HDACi) yielded effective antitumor activity, durable response in patients with relapsed or refractory ENKTL(SCENT trial. Abstracts 644). The investigators next conducted a exploratory study to investigated the safety and efficacy of Sintilimab plus Chidamide(SC) for patients with newly diagnosed ENKTL(SCENT-2 trial).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
1. To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of newly diagnosed ENKTCL patients 2. To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of newly diagnosed ENKTCL patients. 3. Exploring biomarkers that may have predictive effects.
1. To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of newly diagnosed ENKTCL patients 2. To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of newly diagnosed ENKTCL patients. 3. Exploring biomarkers that may have predictive effects.
SunYat-sen university cancer center
Guangzhou, China
RECRUITINGObjective response rate (ORR) after end of treatment
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Time frame: up to 24 months
Complete response rate (CRR) after end of treatment
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Time frame: up to 24 months
Partial response rate (PRR) after end of treatment
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Time frame: up to 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from the treatment date to the date of disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or death regardless of cause.
Time frame: Time Frame: up to 36 months
Overall Survival (OS)
OS is defined as the time from treatment to the date of death.
Time frame: up to 36 months
Duration of Response (DOR)
Among participants who experience an objective response, DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression per the the lymphoma response to immunomodulatory therapy criteria (LYRIC) or death regardless of cause.
Time frame: up to 36 months
Time to disease response (TTR)
Among participants who experience an objective response, TTR is defined as the date of their first administration to the day of their first objective response (which is subsequently confirmed) per the RECIL 2017 Response Criteria for Malignant Lymphoma.
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Time frame: up to 36 months
Time to progression (TTP)
Among all participants, TTP is defined as the date of their first administration to the day of disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or death regardless of cause.
Time frame: Up to 36 months
The frequency of adverse events (adverse events, AEs) and serious adverse events (SAEs)
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
Time frame: Up to 36 months
Objective response rate (ORR) after sintilimab plus chidamide
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Time frame: up to 24 months
Complete response rate (CRR) after sintilimab plus chidamide
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Time frame: up to 24 months
Partial response rate (PRR) after sintilimab plus chidamide
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Time frame: up to 24 months