DEP-Ru Regimen as a Salvage Therapy for HLH
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|ClinicalTrials.gov Identifier: NCT03533790|
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : May 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hemophagocytic Lymphohistiocytosis||Drug: DEP-Ru||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DEP-ruxolitinib Regimen as a Salvage Therapy for Refractory/Relapsed Hemophagocytic Lymphohistiocytosis|
|Estimated Study Start Date :||June 2018|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2021|
doxorubicin (doxorubicin hydrochloride liposome injection) 25 mg/m2 day 1; etoposide 100 mg/m2 was administered day1; methylprednisolone 2 mg/kg days 1 to 5,then gradually reduce; ruxolitinib 0.3mg/kg/d。This regimen was repeated after 2 weeks.
- Evaluation of treatment response [ Time Frame: Change from before and 2,4,6 and 8 weeks after initiating DEP-Ru 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%.
- Survival [ Time Frame: from the time patients received DEP-Ru salvage therapy up to 24 months or June 2021 ]survival
- Adverse events that are related to treatment [ Time Frame: through study completion, an average of 2 years ]Adverse events including 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): NCT03533790
|Contact: jingshi 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|