NCT05775705

Brief Summary

The efficacy and safety of L-DEP (PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone) regimen combined with PD-1 Antibody an induction therapy for Epstein-Barr virus (EBV)-positive lymphoma-associated hemophagocytic lymphohistiocytosis.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
5mo left

Started Aug 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress87%
Aug 2023Oct 2026

First Submitted

Initial submission to the registry

March 8, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

March 8, 2023

Last Update Submit

March 8, 2023

Conditions

PD-1 AntibodyHemophagocytic LymphohistiocytosisEpstein-Barr VirusLymphoma

Outcome Measures

Primary Outcomes (1)

  • Response rate

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

    Two weeks after initiation of L-DEP regimen combined with PD-1 antibody

Secondary Outcomes (4)

  • Response rate of lymphoma

    Four weeks after second cycle of L-DEP and PD-1 antibody regimen

  • Progression Free Survival

    1 years

  • Overall Survival

    1 years

  • Adverse Events

    30 days after last administration of cytotoxic drugs

Study Arms (1)

L-DEP and PD-1 antibody

EXPERIMENTAL

PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone administered in 2 week cycles for 2 cycles

Drug: L-DEP and PD-1 antibody

Interventions

L-DEP and PD-1 antibodyDRUG

Doxorubicin (doxorubicin hydrochloride liposome injection) 35 mg/m2 day 1; etoposide 75 mg/m2 day1; methylprednisolone 1.5mg/kg days 1 to 3, 0.25mg/kg day 4 to 14; PEG-aspargase 6000iu/m2 day2, day4; PD-1 antibody injection 200mg day 5.

L-DEP and PD-1 antibody

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
  • EBV-DNA in peripheral blood \> 1000 copies/ml or EBER detected in tissue specimens.
  • Age 18\~65，gender is not limited.
  • Estimated survival time ≥ 1 month.
  • Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index \>250.
  • Signed informed consent.

You may not qualify if:

  • Heart function above grade II (NYHA).
  • Severe myocardial injury：TNT、TNI、CK-MB \> 3 ULN.
  • 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，etoposide，or PD-1 antibody.
  • Thyroid dysfunction.
  • 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, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Lymphohistiocytosis, HemophagocyticEpstein-Barr Virus InfectionsLymphoma

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-CellHistiocytosisLymphatic DiseasesHemic and Lymphatic DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Zhao Wang, MD

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Wang, MD

CONTACT

63138303wangzhao@ccmu.edu.cn

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
Professor and Head of hematology

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 20, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 20, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)