Sintilimab and Lenalidomide as a Treatment for CAEBV

NCT ID: NCT04518982

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

The experimental group

Group Type: EXPERIMENTAL

Sintilimab and lenalidomide

Intervention Type: DRUG

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

The control group

Group Type: PLACEBO_COMPARATOR

Sintilimab placebo and lenalidomide placebo

Intervention Type: DRUG

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

Interventions

Sintilimab and lenalidomide

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

Intervention Type: DRUG

Sintilimab placebo and lenalidomide placebo

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhao Wang

OTHER

Sponsor Role: lead

Responsible Party

Zhao Wang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

jingshi wang

Role: CONTACT

wangjingshi987@126.com

86-010-63139862

Facility Contacts

jingshi wang

Role: primary

wangjingshi987@126.com

86-010-63139862

Other Identifiers

Sintilimab,Lenalidomide,CAEBV

Identifier Type: -

Identifier Source: org_study_id