L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis
|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: NCT02631109|
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : August 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hemophagocytic Lymphohistiocytosis||Drug: Pegaspargase Drug: doxorubicin Drug: etoposide Drug: methylprednisolone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2019|
Pegaspargase 2000U/m2 day5; doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered once on the first day of every week; methylprednisolone 15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7
100 mg/m2 was administered once on the first day of every week
15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7
- Evaluation of treatment response [ Time Frame: Change from before and 2,4,6 and 8 weeks after initiating L-DEP salvage therapy ]
A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT).
A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was>1.5-fold decreased; ferritin and triglyceride decreased at least 25%; for patients with an initial neutrophil count of<0.5 ×109/L, a response was defined as an increase by at least 100% to>0.5× 109/L; for patients with a neutrophil count of 0.5 to 2.0 × 109/L, an increase by at least 100% to >2.0 × 109/L was considered a response; and for patients with ALT >400 U/L, response was defined as an ALT decrease of at least 50%.
- Change of Epstein-Barr virus(EBV)-DNA [ Time Frame: Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP salvage therapy ]
- Survival [ Time Frame: from the time patients received L-DEP salvage therapy up to 24 months or November 2019 ]
- Adverse events that are related to treatment [ Time Frame: through study completion, an average of 2 years ]Adverse events including pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on.
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): NCT02631109
|Contact: jingshi wang, M.M.||firstname.lastname@example.org|
|Beijing Friendship Hospital, Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: jingshi wang, M.M. 86-13520280731 email@example.com|
|Principal Investigator:||zhao wang, M.D.||Beijing Friendship Hospital|