Status:
UNKNOWN
Pegylated Liposomal Doxorubicin as a Induction Therapy for Lymphoma Induced Hemophagocytic Lymphohistiocytosis.
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Hemophagocytic Lymphohistiocytosis
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
This study aimed to investigate the efficacy and safety of pegylated liposomal doxorubicin together with etoposide and methylprednisolone as a induction therapy for lymphoma induced hemophagocytic lym...
Eligibility Criteria
Inclusion
- Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
- Patients were older than 2 years of age.
- Estimated survival time ≥ 1 week.
- Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index \>250.
- sign informed consent.
Exclusion
- Heart function above grade II (NYHA).
- Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease.
- Pregnancy or lactating Women.
- Allergic to pegylated liposomal doxorubicin or etoposide.
- Active bleeding of the internal organs.
- HIV antibody positivity.
- Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable), acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibody positivity, HCV RNA negative acceptable).
- Participate in other clinical research at the same time.
- The researchers considered that patients are not suitable for the study.
Key Trial Info
Start Date :
August 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04077905
Start Date
August 31 2019
End Date
July 31 2021
Last Update
September 6 2019
Active Locations (1)
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1
Beijing Friendship Hospital
Beijing, China