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

NK/T Cell Lymphoma Nos Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04231370
• Other study ID #: TRhos-ENKTCL-1
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2020
• Source: Beijing Tongren Hospital
• Contact: LIANG WANG, M.D.
• Phone: +8615013009093
• Email: wangliangtrhos[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• NK/T Cell Lymphoma Nos

Intervention

Drug:
• Sintilimab
Sintilimab, 200mg, iv day1
• Lenalidomide
25mg/d oral d1-14

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete response	evaluated by PET-CT and MRI, according to Lugano 2014 criteria	24 weeks ±7 days
Secondary	Rate of overall response	evaluated by PET-CT and MRI, according to Lugano 2014 criteria	24 weeks ±7 days
Secondary	1-year progression free survival rate	time from date of enrollment to date of disease progression, death of any reason, whichever comes first	up to 1year after enrollment
Secondary	1-year overall survival rate	time from date of enrollment to date of death of any reason	up to 1year after enrollment
Secondary	safety profiles	according to CTCAE 4.0	up to 1year after enrollment