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

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04077905

Collaborator

(none)

160

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemophagocytic Lymphohistiocytosis	Drug: Pegylated liposomal doxorubicin Drug: Etoposide Drug: Methylprednisolone	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 31, 2019

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DEP regimen pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles	Drug: Pegylated liposomal doxorubicin 35mg/m² ivgtt on day 1 Drug: Etoposide 100mg/m² ivgtt on day 1 Drug: Methylprednisolone 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,

Arm

Intervention/Treatment

Experimental: DEP regimen

pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles

Drug: Pegylated liposomal doxorubicin

35mg/m² ivgtt on day 1

Drug: Etoposide

100mg/m² ivgtt on day 1

Drug: Methylprednisolone

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,

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts 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.