Sintilimab and Lenalidomide as a Treatment for CAEBV

Sintilimab and Lenalidomide as a Treatment for CAEBV：a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

This study is a multi-center, prospective, randomized, controlled clinical study to evaluate the effectiveness of a combination regimen of Sintilimab and lenalidomide in patients with chronic active EBV infection.

Study Overview

• Status: Unknown
• Conditions: CAEBV
• Intervention / Treatment: Drug: Sintilimab and lenalidomide; Drug: Sintilimab placebo and lenalidomide placebo

• Study Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Friendship Hospital, Capital Medical University
    • Contact: jingshi wang; Phone Number: 86-010-63139862; Email: wangjingshi987@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with CAEBV confirmed by WHO criteria.
2. The Eastern United States Oncology Cooperative group (ECOG) Physical Status score is 0 or 1.
3. Before the study, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× normal upper limit (ULN); Total bilirubin ≤2 times the normal upper limit; Serum creatinine ≤1.5 times the normal value.
4. Absolute neutrophil count ≥1×109/L; Platelet ≥50×109/L; Hemoglobin ≥60 g/L.
5. International standardized ratio ≤2.0, prothrombin time ≤1.5×ULN.
6. A woman of childbearing age must be determined not to be pregnant by a pregnancy test and is willing to take effective measures to prevent pregnancy during the trial period and ≥12 months after the last administration of the drug; All male subjects used contraceptive methods during the study period and ≥6 months after the last administration;
7. Sign the informed consent.

Exclusion Criteria:

1. There is evidence that EBV is associated with hematologic disease or malignancy, such as hemophagocytic syndrome, lymphoma-like granulomatosis, post-transplant lymphoproliferative disease, non-Hodgkin's lymphoma, Burkitt lymphoma, nasopharyngeal cancer, and gastric cancer.
2. Symptomatic EBV-associated diseases of the major organs, including the central nervous system and lungs.
3. Abnormal thyroid function.
4. Patients with grade II or above heart disease (including grade II) were identified according to the New York Heart Association (NYHA) score.
5. Have received any of the following treatments: PD-1 antibody, PD-L1 antibody or lenalidomide; Received any research drug within 12 weeks prior to the first use of the study drug; Another clinical study was also included.
6. Other primary malignancies occur within 5 years before the first administration of the drug, except those that are locally curable after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma of the prostate, cervix or breast in situ, etc.).
7. A history of organ transplantation (such as liver transplantation, kidney transplantation, etc.).
8. Hematopoietic stem cell transplantation is expected during the study period.
9. Active hepatitis B (defined as hepatitis B surface antigen [HBsAg] positive during screening, or hepatitis B virus DNA titer test in peripheral blood greater than 1×103 copies/ml), and active hepatitis C (defined as hepatitis C antibody [HCV-AB] and HCV-RNA positive during screening). Serum HIV antigen or antibody positive. A history of syphilis.
10. Had major surgery within 4 weeks prior to the first medication or was expected to require major surgery during the study period.
11. Pregnant and lactating women;
12. A history of serious mental illness or drug abuse;
13. Uncontrollable infections (including lung infections, intestinal infections, etc.); Internal organ active massive hemorrhage (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.);
14. Allergic to the test drug ingredients or to a more severe allergic constitution;
15. Patients who cannot comply during the trial and/or follow-up phase.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: The control group	Drug: Sintilimab placebo and lenalidomide placebo; Drug: Sintilimab placebo ivgtt on day 1. Drug: lenalidomide placebo orally once a day, day 1-14.
Experimental: The experimental group	Drug: Sintilimab and lenalidomide; Drug: Sintilimab 200mg ivgtt on day 1. Drug: lenalidomide 10mg orally once a day, day 1-14.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	The rate of decline in ebV-DNA copy (defined as a 2log decrease in EBV-DNA copy) or negative rate in peripheral blood mononuclear cells and plasma	Twelve weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spleen size		Twelve weeks after treatment
T and B lymphocyte subsets		Twelve weeks after treatment
Pathological tissue or bone marrow		Twelve weeks after treatment
treatment-related adverse events as assessed by CTCAE v4.0	Adverse events including thyroid function， liver function damage, myelosuppression, infection, bleeding and so on.	through study completion, an average of 1 years
survival	From enrollment until death or the end of the experiment	1 year

Collaborators and Investigators

• Sponsor: Zhao Wang

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: August 16, 2020
• First Submitted That Met QC Criteria: August 16, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 16, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide
• Other Study ID Numbers: Sintilimab,Lenalidomide,CAEBV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No