Back to resultsL-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH
Primary Purpose
PD-1 Antibody, Hemophagocytic Lymphohistiocytosis, Epstein-Barr Virus
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
L-DEP and PD-1 antibody
Sponsored by
About this trial
This is an interventional treatment trial for PD-1 Antibody
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.
Sites / Locations
- Beijing Friendship Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
L-DEP and PD-1 antibody
Arm Description
PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone administered in 2 week cycles for 2 cycles
Outcomes
Primary Outcome Measures
Response rate
complete response (CR) and partial response (PR) rates
Secondary Outcome Measures
Response rate of lymphoma
complete response (CR) and partial response (PR) rates, using the standard response criteria
Progression Free Survival
from date of inclusion to date of progression, relapse, or death from any cause
Overall Survival
from the date of inclusion to date of death, irrespective of cause
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
Full Information
NCT ID
NCT05775705
First Posted
March 8, 2023
Last Updated
March 8, 2023
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05775705
Brief Title
L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH
Official Title
The Efficacy and Safety of L-DEP Regimen Combined With PD-1 Antibody an Induction Therapy for Epstein-Barr Virus (EBV)-Positive Lymphoma-associated Hemophagocytic Lymphohistiocytosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PD-1 Antibody, Hemophagocytic Lymphohistiocytosis, Epstein-Barr Virus, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
L-DEP and PD-1 antibody
Arm Type
Experimental
Arm Description
PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone administered in 2 week cycles for 2 cycles
Intervention Type
Drug
Intervention Name(s)
L-DEP and PD-1 antibody
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response rate
Description
complete response (CR) and partial response (PR) rates
Time Frame
Two weeks after initiation of L-DEP regimen combined with PD-1 antibody
Secondary Outcome Measure Information:
Title
Response rate of lymphoma
Description
complete response (CR) and partial response (PR) rates, using the standard response criteria
Time Frame
Four weeks after second cycle of L-DEP and PD-1 antibody regimen
Title
Progression Free Survival
Description
from date of inclusion to date of progression, relapse, or death from any cause
Time Frame
1 years
Title
Overall Survival
Description
from the date of inclusion to date of death, irrespective of cause
Time Frame
1 years
Title
Adverse Events
Description
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
30 days after last administration of cytotoxic drugs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Wang, MD
Phone
63138303
Email
wangzhao@ccmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Wang, MD
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH
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