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Trial record 4 of 8 for:    "Non-Langerhans-Cell Histiocytosis" | "Antibiotics, Antitubercular"

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

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ClinicalTrials.gov Identifier: NCT04077905
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Zhao Wang, Beijing Friendship Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
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 : August 31, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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,




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


Secondary Outcome Measures :
  1. 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.)

  2. 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

  3. Overall Survival [ Time Frame: Time Frame: 1 years ]
    from the date of inclusion to date of death, irrespective of cause Adverse Events

  4. 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



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077905


Contacts
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Contact: Zhao Wang, PHD 86-1063139862 catenny@hotmail.com

Locations
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China
Beijing Friendship Hospital Recruiting
Beijing, China
Contact: Zhao Wang, PHD    86-63139862    catenny@hotmail.com   
Sponsors and Collaborators
Beijing Friendship Hospital

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Responsible Party: Zhao Wang, Principal Investigator, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT04077905     History of Changes
Other Study ID Numbers: CSPC-DMS-HLH-01
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhao Wang, Beijing Friendship Hospital:
pegylated liposomal doxorubicin
Additional relevant MeSH terms:
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Histiocytosis, Non-Langerhans-Cell
Antibiotics, Antineoplastic
Lymphohistiocytosis, Hemophagocytic
Lymphatic Diseases
Histiocytosis
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Doxorubicin
Liposomal doxorubicin
Etoposide
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists