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

NCT04231370 | Unknown Phase 2

• 1 other identifier: TRhos-ENKTCL-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

NK/T Cell Lymphoma Nos

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of complete response

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

  24 weeks ±7 days

Secondary Outcomes (4)

• Rate of overall response

  24 weeks ±7 days

• 1-year progression free survival rate

  up to 1year after enrollment

• 1-year overall survival rate

  up to 1year after enrollment

• safety profiles

  up to 1year after enrollment

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Drug: Sintilimab; Drug: Lenalidomide

Interventions

Sintilimab DRUG

Sintilimab, 200mg, iv day1

Also known as: anti-PD-1-antibody

treatment arm

Lenalidomide DRUG

25mg/d oral d1-14

Also known as: IMids

treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

sintilimab; spartalizumab; Lenalidomide; Immunomodulating Agents

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jing-wen Wang, M.D.

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LIANG WANG, M.D.

CONTACT

+8615013009093; wangliangtrhos@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Hematology

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

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: April 1, 2020
• Primary Completion: February 28, 2022
• Study Completion: December 31, 2022
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)