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Lenalidomide and Sintilimab for Relapsed/Refractory NK/T-cell Lymphoma

Primary Purpose

NK/T Cell Lymphoma Nos

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Sintilimab

Lenalidomide

About this trial

This is an interventional treatment trial for NK/T Cell Lymphoma Nos focused on measuring pegaspargase, sintilimab, PD-1, lenalidomide, relapsed/refractory

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria.
Previously treated with pegaspargase-based regimens (refractory or relapsed after initial remission).
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>50×10（9）/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Coagulation : plasma fibrinogen ≥ 1.0g / L. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.

Sign the informed consent form.
Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.

Exclusion Criteria:

Patients with a history of pancreatitis.
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 not excluded.
Serious complications such as fulminant DIC.
Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months.
Pregnant and lactating women.
Had a history of autoimmune diseases, and disease was active in the last 6 months, and was still taking oral immunosuppression in the past three 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.

Sites / Locations

Beijing Tongren HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

Sintilimab, 200mg, iv day1 Lenalidomide, 25mg/d, oral, day 1-14 repeated every 3 weeks

Outcomes

Primary Outcome Measures

Rate of complete response

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

Secondary Outcome Measures

Rate of overall response

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

1-year progression free survival rate

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

1-year overall survival rate

time from date of enrollment to date of death of any reason

safety profiles

according to CTCAE 4.0

Full Information

NCT ID

NCT04231370

First Posted

January 14, 2020

Last Updated

May 6, 2020

Sponsor

Beijing Tongren Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04231370

Brief Title

Lenalidomide and Sintilimab for Relapsed/Refractory NK/T-cell Lymphoma

Official Title

Combination of Lenalidomide and Sintilimab for Patients With Relapsed/Refractory NK/T-cell Lymphoma Who Failed Pegaspargase-based Regimens: a Single Arm, Open, Phase II Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

February 28, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with lenalidomide in the treatment of Relapsed/Refractory NK/T-cell lymphoma patients who failed pegaspargase-based regimens.

Detailed Description

Pegaspargase is the backbone of treatment for NK/T-cell lymphoma (ENKTCL), and patients with ENKTCL who failed pegaspargase-based regimens have extremely poor survival outcomes. Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). Constitutive activation of NF-kB pathway has been demonstrated to be involved in the development of ENKTCL and plays critical role in therapy resistance. Lenalidomide, an immuno-modulatory drug, has been found to inhibit NF-kB pathway, and synergize with anti-PD-1 antibody in the treatment of multiple myeloma. Thus, we hypothesize that the combination of lenalidomide and sintilimab will further deepen the remission status and benefit patients who failed pegaspargase-based regimens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NK/T Cell Lymphoma Nos

Keywords

pegaspargase, sintilimab, PD-1, lenalidomide, relapsed/refractory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

treatment with lenalidomide in combination with sintilimab for relapsed/refractory ENKTCL patients

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment arm

Arm Type

Experimental

Arm Description

Sintilimab, 200mg, iv day1 Lenalidomide, 25mg/d, oral, day 1-14 repeated every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Other Intervention Name(s)

anti-PD-1-antibody

Intervention Description

Sintilimab, 200mg, iv day1

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

IMids

Intervention Description

25mg/d oral d1-14

Primary Outcome Measure Information:

Title

Rate of complete response

Description

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

Time Frame

24 weeks ±7 days

Secondary Outcome Measure Information:

Title

Rate of overall response

Description

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

Time Frame

24 weeks ±7 days

Title

1-year progression free survival rate

Description

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

Time Frame

up to 1year after enrollment

Title

1-year overall survival rate

Description

time from date of enrollment to date of death of any reason

Time Frame

up to 1year after enrollment

Title

safety profiles

Description

according to CTCAE 4.0

Time Frame

up to 1year after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria. Previously treated with pegaspargase-based regimens (refractory or relapsed after initial remission). 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>50×10（9）/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Coagulation : plasma fibrinogen ≥ 1.0g / L. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking. Sign the informed consent form. Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations. Exclusion Criteria: Patients with a history of pancreatitis. 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 not excluded. Serious complications such as fulminant DIC. Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months. Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months, and was still taking oral immunosuppression in the past three 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

LIANG WANG, M.D.

Phone

+8615013009093

wangliangtrhos@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing-wen Wang, M.D.

Organizational Affiliation

Beijing Tongren Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Tongren Hospital

City

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liang Wang, MD

Phone

+8615001108693

wangliangtrhos@126.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

All the data in the trial can be shared upon request to the PI.

Learn more about this trial

Lenalidomide and Sintilimab for Relapsed/Refractory NK/T-cell Lymphoma

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