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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hemophagocytic Lymphohistiocytosis
• Intervention / Treatment: Drug: Pegylated liposomal doxorubicin; Drug: Etoposide; Drug: Methylprednisolone

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhao Wang, PHD; Phone Number: 86-1063139862; Email: catenny@hotmail.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Friendship Hospital
    • Contact: Zhao Wang, PHD; Phone Number: 86-63139862; Email: catenny@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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,

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Publications and helpful links

General Publications

• 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. 2022 Jul 19. doi: 10.1007/s00432-022-04157-0. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2019
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: August 31, 2019
• First Submitted That Met QC Criteria: August 31, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: pegylated liposomal doxorubicin
• Additional Relevant MeSH Terms: Lymphatic Diseases; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphohistiocytosis, Hemophagocytic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Methylprednisolone; Etoposide; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: CSPC-DMS-HLH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No