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

NCT ID: NCT04231370

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2022-12-31

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.

Conditions

NK/T Cell Lymphoma Nos

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

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

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

Sintilimab, 200mg, iv day1

Lenalidomide

Intervention Type: DRUG

25mg/d oral d1-14

Interventions

Sintilimab

Sintilimab, 200mg, iv day1

Intervention Type: DRUG

Lenalidomide

25mg/d oral d1-14

Intervention Type: DRUG

Other Intervention Names

anti-PD-1-antibody; IMids

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

JING-WEN WANG

Professor of Department of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing-wen Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Locations

Beijing Tongren Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

LIANG WANG, M.D.

Role: CONTACT

wangliangtrhos@126.com

+8615013009093

Facility Contacts

Liang Wang, MD

Role: primary

wangliangtrhos@126.com

+8615001108693

Other Identifiers

TRhos-ENKTCL-1

Identifier Type: -

Identifier Source: org_study_id