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

Phase 3

• Conditions: Hemophagocytic Lymphohistiocytosis
• Interventions: Drug: Pegylated liposomal doxorubicin; Drug: Etoposide; Drug: Methylprednisolone

• Registration Number: NCT04077905
• Lead Sponsor: Beijing Friendship Hospital

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 lymphohistiocytosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-31
• Study First Submitted: 2019-08-31
• Study First Submitted QC: 2019-08-31
• Status Verified: 2019-09
• Study First Posted: 2019-09-04
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEP regimen	Pegylated liposomal doxorubicin	pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles
DEP regimen	Methylprednisolone	pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles
DEP regimen	Etoposide	pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles

Primary Outcome Measures

Name	Time	Method
Response rate	Time Frame: 1 years	complete response (CR) and partial response (PR) rates

Secondary Outcome Measures

Name	Time	Method
Response rate of lymphoma	Time Frame: 1 years	complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.)
Overall Survival	Time Frame: 1 years	from the date of inclusion to date of death, irrespective of cause Adverse Events
Adverse Events	Time Frame: 1 years	any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Progression Free Survival	Time Frame: 1 years	from date of inclusion to date of progression, relapse, or death from any cause Overall Survival

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, China