PD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04084626|
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : February 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|EBV Infection||Drug: PD1 antibody Drug: lenalidomide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: PD-1 antibody
PD-1 antibody and lenalidomide administered in 2 week cycles for 6 cycles.
Drug: PD1 antibody
2mg/kg ivgtt on day 1(age<18 years); 200mg ivgtt on day 1(age >=18 years).
5mg orally once a day（age<18years) ,day 1-14; 10mg orally once a day(age>=18years), day 1-14.
- Change of Epstein-Barr virus(EBV)-DNA [ Time Frame: 6 months ]PBMC and plasma EBV-DNA
- The spleen size [ Time Frame: 6 months ]Ultrasonic spleen size
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: through study completion, an average of 1 years ]Adverse events including thyroid function， liver function damage, myelosuppression, infection, bleeding and so on.
- survival [ Time Frame: 1 year ]from the date of inclusion to date of death, irrespective of cause Adverse Events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084626
|Contact: jingshi firstname.lastname@example.org|
|Beijing Friendship Hospital, Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: jingshi wang|