NCT04077905

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

August 31, 2019

Last Update Submit

September 4, 2019

Conditions

Hemophagocytic Lymphohistiocytosis

Keywords

pegylated liposomal doxorubicin

Outcome Measures

Primary Outcomes (1)

  • Response rate

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

    Time Frame: 1 years

Secondary Outcomes (4)

  • Response rate of lymphoma

    Time Frame: 1 years

  • Progression Free Survival

    Time Frame: 1 years

  • Overall Survival

    Time Frame: 1 years

  • Adverse Events

    Time Frame: 1 years

Study Arms (1)

DEP regimen

EXPERIMENTAL

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

Drug: Pegylated liposomal doxorubicinDrug: EtoposideDrug: Methylprednisolone

Interventions

Pegylated liposomal doxorubicinDRUG

35mg/m² ivgtt on day 1

DEP regimen
EtoposideDRUG

100mg/m² ivgtt on day 1

DEP regimen
MethylprednisoloneDRUG

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,

DEP regimen

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
  • Patients were older than 2 years of age.
  • Estimated survival time ≥ 1 week.
  • Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index \>250.
  • sign informed consent.

You may not qualify if:

  • Heart function above grade II (NYHA).
  • Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease.
  • Pregnancy or lactating Women.
  • Allergic to pegylated liposomal doxorubicin or etoposide.
  • Active bleeding of the internal organs.
  • HIV antibody positivity.
  • 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).
  • Participate in other clinical research at the same time.
  • The researchers considered that patients are not suitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35852619DERIVED

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

liposomal doxorubicinEtoposideMethylprednisolone

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-CellHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Central Study Contacts

Zhao Wang, PHD

CONTACT

86-1063139862catenny@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2019

First Posted

September 4, 2019

Study Start

August 31, 2019

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)