L-DEP Regimen Combined With PD-1 Antibody as Induction Th... | NCT05775705

Studies
L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH

NCT05775705

Sponsor

Beijing Friendship Hospital

Status

Not yet recruiting

Last Update Posted

Mar 20, 2023Actual

Enrollment

25Estimated

Phase

Phase 3

Conditions

PD-1 Antibody
Hemophagocytic Lymphohistiocytosis
Epstein-Barr Virus
Lymphoma

Interventions

L-DEP and PD-1 antibody

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Estimated

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Oct 1, 2026Estimated

First Submitted Date

Mar 8, 2023

First Submission Date that Met QC Criteria

Mar 8, 2023

First Posted Date

Mar 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2023

Last Update Posted Date

Mar 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Without early intervention, the median survival time is less than 2 months. Currently, HLH-94 or HLH-04 are the standard HLH treatment regimens, which have improved the disease response rate to approximately 70% and increased the 5-year OS rate to 50%. However, approximately, 30% of the patients remain unresponsive to standard therapy, especially if HLH is lymphoma-associated. Therefore, we conduct a prospective clinical study to explore 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
L-DEP and PD-1 antibody	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Response rate of lymphoma	complete response (CR) and partial response (PR) rates, using the standard response criteria	Four weeks after second cycle of L-DEP and PD-1 antibody regimen
Progression Free Survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhao Wang, MD	Contact	63138303		wangzhao@ccmu.edu.cn

Overall Officials

Name	Affiliation	Role
Zhao Wang, MD	Beijing Friendship Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Friendship Hospital, Capital Medical University		Beijing	Beijing Municipality	100050	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051359	Lymphohistiocytosis, Hemophagocytic
D020031	Epstein-Barr Virus Infections
D008223	Lymphoma

Ancestor Terms

ID	Term
D015616	Histiocytosis, Non-Langerhans-Cell
D015614	Histiocytosis
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

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Browse Branches

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