Clinical trial · Interventional
PD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV
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)
NCT04084626CI-TRIAL-00055816unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EBV Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
| PD1 antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 antibody
- description
- PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles.
- interventionNames
- Drug: PD1 antibody
- Drug: lenalidomide
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 6 months
- description
- 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 outcomes (3)
- measure
- Spleen size
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.