L-DEP as an Initial Treatment for EBV-HLH
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02912702|
Recruitment Status : Unknown
Verified September 2016 by Zhao Wang, Beijing Friendship Hospital.
Recruitment status was: Recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hemophagocytic Lymphohistiocytosis||Drug: Pegaspargase Drug: doxorubicin hydrochloride liposome injection Drug: etoposide Drug: methylprednisolone Drug: Etoposide Drug: dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of L-DEP as an Initial Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2019|
Pegaspargase 2000U/m2 day5; 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
Drug: doxorubicin hydrochloride liposome injection
25 mg/m2 day 1
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
Active Comparator: HLH-94 regimen
Etoposide 150 mg/m2 twice weekly for 2 weeks and then weekly; dexamethasone initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering
150 mg/m2 twice weekly for 2 weeks and then weekly
initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering
- Overall response(complete response+ partial response) rate of Participants [ Time Frame: Change from before and 2,4,6 and 8 weeks after initiating L-DEP or HLH-94 therapy ]
A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25(pg/ml), ferritin(μg/L), and triglyceride(mmol/L); hemoglobin(g/L); neutrophil counts(×109/L); platelet counts(×109/L); and alanine aminotransferase (ALT(U/L)).
A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25(pg/ml) response was>1.5-fold decreased; ferritin (μg/L)and triglyceride(mmol/L) 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 (U/L)decrease of at least 50%.
- Compare survival between two arms [ Time Frame: from the time patients received L-DEP or HLH-94 therapy up to 12 months or September 2019 ]
- 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 pancreatitis, liver function damage, myelosuppression, infection, bleeding and so on.
- Change of Epstein-Barr virus(EBV)-DNA before and after therapy [ Time Frame: Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP or HLH-94 therapy ]
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): NCT02912702
|Contact: jingshi wang, M.M.||email@example.com|
|Beijing Friendship Hospital, Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: jingshi wang, M.M. 86-13520280731 firstname.lastname@example.org|