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Status unknownNCT04077905Updated Sep 6, 2019

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

A Phase 3 interventional study of Pegylated liposomal doxorubicin and Etoposide in Hemophagocytic Lymphohistiocytosis, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2019-09-06.

Sponsored by Beijing Friendship Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Not applicable
Ages
2 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hemophagocytic Lymphohistiocytosis

Keywords

  • pegylated liposomal doxorubicin
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In context

Lymphohistiocytosis, Hemophagocytic

100 studies on the registry are indexed under Lymphohistiocytosis, Hemophagocytic; 35 are open to participants now.

This study's planned enrollment of 160 is above the median of 30 across 69 interventional studies indexed under Lymphohistiocytosis, Hemophagocytic.

Browse Lymphohistiocytosis, Hemophagocytic studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 217 studies on the registry; 94 are open to participants now.

Browse Beijing Friendship Hospital studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    DEP regimen

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

    Drug: Pegylated liposomal doxorubicin · Drug: Etoposide · Drug: Methylprednisolone

Interventions

06

What researchers measure

Primary outcomes

  1. Response rate

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

    Time frame: Time Frame: 1 years

Secondary outcomes

  1. Response rate of lymphoma

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

    Time frame: Time Frame: 1 years

  2. Progression Free Survival

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

    Time frame: Time Frame: 1 years

  3. Overall Survival

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

    Time frame: Time Frame: 1 years

  4. 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: Time Frame: 1 years

07

Study locations

1 of 1 sites recruiting
  • Beijing Friendship Hospital
    Beijing, China
    Recruiting
08

References and documents

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. 2023 Jul;149(7):3033-3041. doi: 10.1007/s00432-022-04157-0. Epub 2022 Jul 19. PubMed 35852619 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2019 (actual). Primary completion is estimated for Jul 2021, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2019
First posted
Sep 4, 2019
StartActual
Aug 31, 2019
Primary completionEst.
Jul 31, 2021
CompletionEst.
Jul 31, 2021
Last update
Sep 6, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04077905
Lead sponsor
Beijing Friendship Hospital
Responsible party
Zhao Wang (Principal Investigator, Beijing Friendship Hospital) — Principal investigator
First posted
Sep 4, 2019
Start date
Aug 31, 2019
Primary completion
Jul 31, 2021 (estimated)
Completion
Jul 31, 2021 (estimated)
Last update
Sep 6, 2019

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Liposomal doxorubicin

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