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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study on the Modified DEP Regimen Induction Therapy in Lymphoma Induced Hemophagocytic Lymphohistiocytosis

Conditions
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Hemophagocytic Lymphohistiocytosis

Intervention / Treatment
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* Drug: Pegylated liposomal doxorubicin
* Drug: Etoposide
* Drug: Methylprednisolone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEP regimen<br>pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles | Drug: Pegylated liposomal doxorubicin<br>* 35mg/m² ivgtt on day 1<br>Drug: Etoposide<br>* 100mg/m² ivgtt on day 1<br>Drug: Methylprednisolone<br>* 2 mg/kg ivgtt or PO days 1 to 3, 0.75 mg/kg ivgtt or PO days 4 to 7, 0.25 mg/kg ivgtt or PO days 8 to 10, 0. 1 mg/kg ivgtt or PO days 11 to 14,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | complete response (CR) and partial response (PR) rates | Time Frame: 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of lymphoma | complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.) | Time Frame: 1 years | 
| Progression Free Survival | from date of inclusion to date of progression, relapse, or death from any cause Overall Survival | Time Frame: 1 years | 
| Overall Survival | from the date of inclusion to date of death, irrespective of cause Adverse Events | Time Frame: 1 years | 
| Adverse Events | 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 | Time Frame: 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pegylated liposomal doxorubicin