Pegylated Liposomal Doxorubicin as a Induction Therapy for Lymphoma Induced Hemophagocytic Lymphohistiocytosis.

Capital Medical University

Status and phase

Unknown

Phase 3

Conditions

Hemophagocytic Lymphohistiocytosis

Treatments

Drug: Methylprednisolone

Drug: Pegylated liposomal doxorubicin

Drug: Etoposide

Study type

Interventional

Funder types

Other

Identifiers

NCT04077905

CSPC-DMS-HLH-01

Details and patient eligibility

About

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 lymphohistiocytosis.

Enrollment

160 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1.Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
2.Patients were older than 2 years of age.
3.Estimated survival time ≥ 1 week.
4.Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index >250.
5.sign informed consent.

Exclusion criteria

1.Heart function above grade II (NYHA).
2.Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease.
3.Pregnancy or lactating Women.
4.Allergic to pegylated liposomal doxorubicin or etoposide.
5.Active bleeding of the internal organs.
6.HIV antibody positivity.
7.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).
8.Participate in other clinical research at the same time.
9.The researchers considered that patients are not suitable for the study.