PD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV

EBV Infection Clinical Trial

Official title:

A Clinical Trial of Programmed Cell Death Protein 1(PD1) Antibody and Lenalidomide as a Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis or Chronic Active EBV Infection(CAEBV)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04084626
• Other study ID #: PD-1 antibody-EBV
• Status: Recruiting
• Phase: Phase 3
• Start date: September 15, 2019
• Est. completion date: July 1, 2022

Study information

• Verified date: January 2022
• Source: Beijing Friendship Hospital
• Contact: jingshi wang
• Phone: 86-010-63139862
• Email: wangjingshi987[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study was a prospective one-arm clinical study, in which EBV-HLH/chronic active EBV infection patients were selected as the main subjects to evaluate the effect of PD-1 antibody and lenalidomide regimens on ebv-dna and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 65 Years

Eligibility

Inclusion Criteria:

1. Patients with CAEBV confirmed by 2016 Revised World Health Organization classification.

2. If the patient has previously suffered CAEBV-HLH, the HLH should be in remission.

3. 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;

4. Ages Eligible for Study: 1 Year to 65 Years.

5. Sign the informed consent.

Exclusion Criteria:

1. Heart function above grade II (NYHA).

2. Pregnancy or lactating Women.

3. Allergic to PD-1 antibody or lenalidomide.

4. Active bleeding of the internal organs.

5. uncontrollable infection.

6. Participate in other clinical research at the same time.

Related Conditions & MeSH terms

• EBV Infection
• Epstein-Barr Virus Infections
• Infections

Intervention

Drug:
• PD1 antibody
2mg/kg ivgtt on day 1(age<18 years); 200mg ivgtt on day 1(age >=18 years).
• lenalidomide
5mg orally once a day(age<18years) ,day 1-14; 10mg orally once a day(age>=18years), day 1-14.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	Spleen size	ultrasonic spleen size	6 months
Secondary	Number of participants with 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
Secondary	survival	from the date of inclusion to date of death, irrespective of cause Adverse Events	1 year