Modified DEP Regimens for the Treatment of Hemophagocytic Lymphohistiocytosis

NCT06504030 | Not Yet Recruiting Phase 4

• 1 other identifier: modified-DEP
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is trying to evaluate the efficacy and safety of modified DEP regimens for the treatment of active hemophagocytic lymphohistiocytosis.

Conditions

Hemophagocytic Lymphohistiocytoses

Outcome Measures

Primary Outcomes (2)

• Response rate of modified-DEP

  Rates of complete response, partial response, improvement

  2 weeks, 4 weeks, 6 weeks, 8 weeks

• Incidence of Treatment-Emergent Adverse Events

  Rates of adverse events

  2 weeks, 4 weeks, 6 weeks, 8 weeks

Secondary Outcomes (1)

• Survival of patients

  3 months, 6 months, 1 year

Study Arms (1)

modified-DEP for HLH

EXPERIMENTAL

modified-DEP for the treatment of non-EBV-HLH and EBV-HLH patients.

Drug: modified-DEP

Interventions

modified-DEP DRUG

For non-EBV-HLH patients: Liposomes doxorubicin, 25 mg/m2 d1, etoposide 100 mg/m2 d1, methylprednisolone 1 mg/kg d1-3, then tapering according to patients condition, fully stop with d7 to d10; ruxolitinib, 15 mg bid. Emapalumab, if needed. For EBV-HLH patients: PD-1 monoclonal antibody, 2 mg/kg (maximum dose, 200 mg) d-3, liposomes doxorubicin, 25 mg/m2 d1, etoposide 100 mg/m2 d1, methylprednisolone 1 mg/kg d1-3, then tapering according to patients condition, fully stop with d7 to d10; ruxolitinib, 15 mg bid. Emapalumab, if needed.

modified-DEP for HLH

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• According to the HLH-2004 criteria, the patient meets the HLH diagnosis.
• year old \< age \< 70 years old, regardless of gender.
• Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times the normal value; fibrinogen can be corrected to ≥ 0.6g/L after infusion.
• \. Serum HIV antibody negative; HCV antibody negative, or HCV antibody positive, but HCV-RNA negative. HBV surface antigen and HBV core antibody are both negative. If any of the above is positive, peripheral blood hepatitis B virus DNA titer detection is required, and it must be less than 1×103 copies/ml before enrollment.
• \. Women of childbearing age must be confirmed to be non-pregnant through pregnancy tests, and are willing to take effective contraceptive measures during the trial and within ≥ 6 months after the last dose; pregnant and lactating women cannot participate; all male subjects take contraceptive measures during the trial and within ≥ 3 months after the last dose.
• \. Sign the informed consent form.

You may not qualify if:

• Allergic to liposome doxorubicin, etoposide, and ruxolitinib or with severe allergic constitution;
• Severe myocardial damage, with myocardial enzyme CK and CK-MB increased more than 3 times ULN (upper limit of normal value).
• Patients with heart disease of grade II or above (including grade II) according to the New York Heart Association (NYHA) score.
• Subjects who have used a total cumulative dose of doxorubicin ≥300mg/m2 or a total cumulative dose of epirubicin ≥450mg/m2, or who have previously used anthracyclines to cause heart disease.
• Subjects with severe mental illness;
• Severe and uncontrollable infections, such as lung infection, intestinal infection, and sepsis.
• Active massive bleeding in visceral organs (including gastrointestinal bleeding, alveolar bleeding, intracranial bleeding, etc.);
• Patients who are unable to rely during the trial and/or follow-up stage and who are participating in other clinical studies at the same time.
• For patients who intend to use PD-1 monoclonal antibodies, if the patient has any of the following conditions, PD-1 monoclonal antibodies will not be used, and only the DEP regimen that does not contain PD-1 monoclonal antibodies will be used:
• Those who are allergic to PD-1 monoclonal antibody components.
• Abnormal thyroid function.
• Those who have other severe immune reaction tendencies, including immune myocardial injury, immune hepatitis, immune pneumonia, etc.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Xuefeng He, Dr

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuefeng He, Dr

CONTACT

86-18914031640; hexuefeng@suda.edu.cn

Yue Song, Dr

CONTACT

86-18810253070; xueqifeng1992@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 5, 2024

Record last verified: 2024-08