Status:
NOT_YET_RECRUITING
Modified DEP Regimens for the Treatment of Hemophagocytic Lymphohistiocytosis
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Hemophagocytic Lymphohistiocytoses
Eligibility:
All Genders
1-70 years
Phase:
PHASE4
Brief Summary
This study is trying to evaluate the efficacy and safety of modified DEP regimens for the treatment of active hemophagocytic lymphohistiocytosis.
Detailed Description
In the investigators' previous clinical practice, it has been found that under the condition of combined treatment with safer inflammatory factors such as ruxolitinib and CCRT, further reducing the do...
Eligibility Criteria
Inclusion
- According to the HLH-2004 criteria, the patient meets the HLH diagnosis.
- 1 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.
- 3\. 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.
- 4\. 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.
- 5\. Sign the informed consent form.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06504030
Start Date
August 1 2024
End Date
February 1 2027
Last Update
August 5 2024
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