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

Phase 3

• Conditions: EBV Infection
• Interventions: Drug: PD1 antibody; Drug: lenalidomide

• Registration Number: NCT04084626
• Lead Sponsor: Beijing Friendship Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-08
• Study First Submitted QC: 2019-09-08
• Study First Posted: 2019-09-10
• Study Start: 2019-09-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-05
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-1 antibody	PD1 antibody	PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles.
PD-1 antibody	lenalidomide	PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles.

Primary Outcome Measures

Name	Time	Method
Response rate	6 months	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

Secondary Outcome Measures

Name	Time	Method
Spleen size	6 months	ultrasonic spleen size
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	through study completion, an average of 1 years	Adverse events including thyroid function， liver function damage, myelosuppression, infection, bleeding and so on.
survival	1 year	from the date of inclusion to date of death, irrespective of cause Adverse Events

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China