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

Overview

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.

Full Title of Study: “A Prospective Study on the Modified DEP Regimen Induction Therapy in Lymphoma Induced Hemophagocytic Lymphohistiocytosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2021

Interventions

  • 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,

Arms, Groups and Cohorts

  • Experimental: DEP regimen
    • pegylated liposomal doxorubicin, etoposide and methylprednisolone administered in 2 week cycles for 2 cycles

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Response rate of lymphoma
    • Time Frame: 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: Time Frame: 1 years
    • from date of inclusion to date of progression, relapse, or death from any cause Overall Survival
  • Overall Survival
    • Time Frame: Time Frame: 1 years
    • from the date of inclusion to date of death, irrespective of cause Adverse Events
  • Adverse Events
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Friendship Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhao Wang, Principal Investigator – Beijing Friendship Hospital
  • Overall Contact(s)
    • Zhao Wang, PHD, 86-1063139862, catenny@hotmail.com

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