Sintilimab and Lenalidomide as a Treatment for CAEBV

NCT04518982 | Unknown Phase 2

• 1 other identifier: Sintilimab,Lenalidomide,CAEBV
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CAEBV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  through study completion, an average of 1 years

• survival

  1 year

Study Arms (2)

The experimental group

EXPERIMENTAL

Drug: Sintilimab and lenalidomide

The control group

PLACEBO COMPARATOR

Drug: Sintilimab placebo and lenalidomide placebo

Interventions

Sintilimab and lenalidomide DRUG

Drug: Sintilimab 200mg ivgtt on day 1. Drug: lenalidomide 10mg orally once a day, day 1-14.

The experimental group

Sintilimab placebo and lenalidomide placebo DRUG

Drug: Sintilimab placebo ivgtt on day 1. Drug: lenalidomide placebo orally once a day, day 1-14.

The control group

Eligibility Criteria

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

You may qualify if:

• Patients with CAEBV confirmed by WHO criteria.
• The Eastern United States Oncology Cooperative group (ECOG) Physical Status score is 0 or 1.
• 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.
• Absolute neutrophil count ≥1×109/L; Platelet ≥50×109/L; Hemoglobin ≥60 g/L.
• International standardized ratio ≤2.0, prothrombin time ≤1.5×ULN.
• 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;
• Sign the informed consent.

You may not qualify if:

• 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.
• Symptomatic EBV-associated diseases of the major organs, including the central nervous system and lungs.
• Abnormal thyroid function.
• Patients with grade II or above heart disease (including grade II) were identified according to the New York Heart Association (NYHA) score.
• 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.
• 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.).
• A history of organ transplantation (such as liver transplantation, kidney transplantation, etc.).
• Hematopoietic stem cell transplantation is expected during the study period.
• 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.
• Had major surgery within 4 weeks prior to the first medication or was expected to require major surgery during the study period.
• Pregnant and lactating women;
• A history of serious mental illness or drug abuse;
• Uncontrollable infections (including lung infections, intestinal infections, etc.); Internal organ active massive hemorrhage (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.);
• Allergic to the test drug ingredients or to a more severe allergic constitution;
• Patients who cannot comply during the trial and/or follow-up phase.

Sponsors & Collaborators

• Zhao Wang: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Interventions

sintilimab; Lenalidomide

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

Central Study Contacts

jingshi wang

CONTACT

86-010-63139862; wangjingshi987@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 19, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)