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

Primary Purpose

Hemophagocytic Lymphohistiocytosis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Pegylated liposomal doxorubicin

Etoposide

Methylprednisolone

About this trial

This is an interventional treatment trial for Hemophagocytic Lymphohistiocytosis focused on measuring pegylated liposomal doxorubicin

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Beijing Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DEP regimen

Arm Description

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

Outcomes

Primary Outcome Measures

Response rate

complete response (CR) and partial response (PR) rates

Secondary Outcome Measures

Response rate of lymphoma

complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.)

Progression Free Survival

from date of inclusion to date of progression, relapse, or death from any cause Overall Survival

Overall Survival

from the date of inclusion to date of death, irrespective of cause Adverse Events

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

Full Information

NCT ID

NCT04077905

First Posted

August 31, 2019

Last Updated

September 4, 2019

Sponsor

Beijing Friendship Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04077905

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 31, 2019 (Actual)

Primary Completion Date

July 31, 2021 (Anticipated)

Study Completion Date

July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophagocytic Lymphohistiocytosis

Keywords

pegylated liposomal doxorubicin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DEP regimen

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pegylated liposomal doxorubicin

Intervention Description

35mg/m² ivgtt on day 1

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Description

100mg/m² ivgtt on day 1

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Intervention Description

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,

Primary Outcome Measure Information:

Title

Response rate

Description

complete response (CR) and partial response (PR) rates

Time Frame

Time Frame: 1 years

Secondary Outcome Measure Information:

Title

Response rate of lymphoma

Description

complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.)

Time Frame

Time Frame: 1 years

Title

Progression Free Survival

Description

from date of inclusion to date of progression, relapse, or death from any cause Overall Survival

Time Frame

Time Frame: 1 years

Title

Overall Survival

Description

from the date of inclusion to date of death, irrespective of cause Adverse Events

Time Frame

Time Frame: 1 years

Title

Adverse Events

Description

Time Frame

Time Frame: 1 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhao Wang, PHD

Phone

86-1063139862

catenny@hotmail.com

Facility Information:

Facility Name

Beijing Friendship Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhao Wang, PHD

Phone

86-63139862

catenny@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35852619

Citation

Pi Y, Wang J, Zhou H, Ye X, Sun X, Liu L, Pan X, Wang Z. Modified DEP regimen as induction therapy for lymphoma-associated hemophagocytic lymphohistiocytosis: a prospective, multicenter study. J Cancer Res Clin Oncol. 2023 Jul;149(7):3033-3041. doi: 10.1007/s00432-022-04157-0. Epub 2022 Jul 19.

Results Reference

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

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