## Protocol Section
### Identification Module
**NCT ID:** NCT04279379

**Brief Title:** Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma

**Official Title:** Combination of Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study

#### Organization Study ID Info
**ID:** TRhos-ENKTCL-2
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tongren Hospital
### Status Module
#### Completion Date
**Date:** 2022-12-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-05-07

**Type:** ACTUAL

**Last Update Submit Date:** 2020-05-06

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-04-01

**Type:** ACTUAL

**Status Verified Date:** 2020-05

#### Study First Post Date
**Date:** 2020-02-21
**Type:** ACTUAL
**Study First Submit Date:** 2020-02-19
**Study First Submit QC Date:** 2020-02-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Tongren Hospital

#### Responsible Party

**Investigator Affiliation:** Beijing Tongren Hospital

**Investigator Full Name:** JING-WEN WANG

**Investigator Title:** Director of department of hematology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with decitabine in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients

**Detailed Description:** Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). However, the CR rate of PD-1 antibody monotherapy is too low. Previous studies have demonstrated that decitabine may activate the T cells and enhance the efficacy of PD-1 antibodies in Hodgkin Lymphoma. Thus, the investigators aim to evaluate the efficacy and safety of sintilimab in combination with decitabine in the treatment of NK/T cell lymphoma.

### Conditions Module

**Conditions:**

- Extranodal NK/T-cell Lymphoma

**Keywords:**

- extranodal NK/T-cell lymphoma

- PD-1 blockade

- decitabine

- sintilimab

- hypomethylation

- epigenetics

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** treatment with sintilimab and decitabine.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Sintilimab,200mg,ivdrip,day1 Decitabine 10mg d1-5, ivdrip, repeated every 3 weeks.

**Intervention Names:**

- Drug: Sintilimab

- Drug: Decitabine

**Label:** treatment arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- treatment arm

**Description:** 200mg d1,ivdrip, repeated every 3 weeks

**Name:** Sintilimab

**Other Names:**

- anti-PD-1-antibody

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- treatment arm

**Description:** 10mg d1-5, ivdrip,repeated every 3 weeks

**Name:** Decitabine

**Other Names:**

- hypomethylating agents

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** evaluated by PET-CT and MRI, according to Lugano 2014 criteria

**Measure:** complete response rate

**Time Frame:** 24 weeks ±7 days

#### Secondary Outcomes

**Description:** evaluated by PET-CT and MRI, according to Lugano 2014 criteria

**Measure:** overall response rate

**Time Frame:** 24 weeks ±7 days

**Description:** time from date of enrollment to date of disease progression, death of any reason, whichever comes first

**Measure:** 1-year progression free survival rate

**Time Frame:** up to 1year after enrollment

**Description:** time from date of enrollment to date death of any reason

**Measure:** 1-year overall survival rate

**Time Frame:** up to 1year after enrollment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.

* refractory or relapsed after initial remission, or stage III-IV de novo patients
* PET/CT or CT/MRI with at least one objectively evaluable lesion.
* General status ECOG score 0-3 points.
* The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb\>80g/L, PLT\>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
* Sign the informed consent form

Exclusion Criteria:

Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.

Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.

Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months.

• Other experimental drugs are being used.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wangliangtrhos@126.com

**Name:** LIANG WANG, M.D.

**Phone:** +8615013009093

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** wangliangtrhos@126.com

- **Name:** Liang Wang, MD

- **Phone:** +8615001108693

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Tongren Hospital

**Status:** RECRUITING

**Zip:** 100730

#### Overall Officials

**Official 1:**

**Affiliation:** Beijing Tongren Hospital

**Name:** Jing-wen Wang, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M18829

- Name: Lymphoma, T-Cell

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: M18833

- Name: Lymphoma, T-Cell, Peripheral

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: M27676

- Name: Lymphoma, Extranodal NK-T-Cell

- Relevance: HIGH

- As Found: Extranodal NK/T-cell Lymphoma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T4496

- Name: Peripheral T-cell Lymphoma

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: T2165

- Name: Extranodal Nasal NK/T Cell Lymphoma

- Relevance: HIGH

- As Found: NK/T-cell Lymphoma

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000016399

- Term: Lymphoma, T-Cell

- ID: D000016411

- Term: Lymphoma, T-Cell, Peripheral

- ID: D000054391

- Term: Lymphoma, Extranodal NK-T-Cell

### Intervention Browse Module - Ancestors

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1697

- Name: Decitabine

- Relevance: HIGH

- As Found: Above

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077209

- Term: Decitabine

### Misc Info Module

- Version Holder: 2024-05-24
