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Status unknownNCT04084626Updated Jan 5, 2022

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

A Phase 3 interventional study of PD1 antibody and lenalidomide in EBV Infection, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 1 Year to 65 Years. Per ClinicalTrials.gov, last updated 2022-01-05.

Sponsored by Beijing Friendship Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
1 Year to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • EBV Infection
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 40 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    PD-1 antibody

    PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles.

    Drug: PD1 antibody · Drug: lenalidomide

Interventions

  • DrugPD1 antibody

    2mg/kg ivgtt on day 1(age\<18 years); 200mg ivgtt on day 1(age \>=18 years).

  • Druglenalidomide

    5mg orally once a day（age\<18years) ,day 1-14; 10mg orally once a day(age\>=18years), day 1-14.

06

What researchers measure

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

    Time frame: 6 months

Secondary outcomes

  1. Spleen size

    ultrasonic spleen size

    Time frame: 6 months

  2. 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.

    Time frame: through study completion, an average of 1 years

  3. survival

    from the date of inclusion to date of death, irrespective of cause Adverse Events

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing 100050, China
    • jingshi wang · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04084626
Lead sponsor
Beijing Friendship Hospital
Responsible party
Zhao Wang (Principal Investigator, Beijing Friendship Hospital) — Principal investigator
First posted
Sep 10, 2019
Start date
Sep 15, 2019
Primary completion
Jul 1, 2022 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
Jan 5, 2022

Study contacts

jingshi wang
Contact
wangjingshi987@126.com
86-010-63139862

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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