ClinicalTrials.gov record NCT06504030
Modified DEP Regimens for the Treatment of Hemophagocytic Lymphohistiocytosis
A Single-arm, Single-center, Prospective Study of Modified DEP Regimens (Doxorubicin+ Etoposide + Methylprednisolone) for the Treatment of Hemophagocytic Lymphohistiocytosis
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a single-arm, single-center, prospective Phase 4 study that observes a modified DEP drug regimen in people with active hemophagocytic lymphohistiocytosis (HLH). The study gives the modified DEP regimen to all participants (no control group), though the exact regimen differs by EBV status; it records response and side effects over early weeks, with longer-term survival follow-up. The regimen differs for EBV-associated versus non-EBV HLH in the protocol.
What it is studying. The study is testing the effectiveness and safety of a modified DEP regimen (doxorubicin + etoposide + methylprednisolone) given with ruxolitinib; for EBV-HLH the protocol may include a PD-1 monoclonal antibody, and emapalumab may be used if needed. It aims to measure response rates and treatment-emergent adverse events in the weeks after treatment and to track survival over months.
What the researchers hope to learn. To determine response rates (complete, partial, improvement) and rates of treatment-emergent adverse events at early time points, and to record patient survival at 3 months, 6 months, and 1 year.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This study is trying to evaluate the efficacy and safety of modified DEP regimens for the treatment of active hemophagocytic lymphohistiocytosis.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- modified-DEP
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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 dosage of high-dose hormones and shortening the duration of use can effectively reduce the occurrence of adverse reactions while still achieving the effect of effectively alleviating HLH. This study is a prospective clinical study aimed at observing the effectiveness and safety of the modified DEP regimen in the treatment of active HLH.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive the study's modified‑DEP drug regimen (liposomal doxorubicin, etoposide, methylprednisolone) with ruxolitinib; people with EBV‑HLH may also receive a PD‑1 monoclonal antibody before the regimen and emapalumab may be used if needed. They will have regular clinic visits for monitoring, blood tests, and safety assessments, plus pregnancy testing and contraception verification; cardiac testing is done as part of eligibility and safety evaluation when indicated. Study outcomes are assessed at multiple early time points (for example 2–8 weeks) and with longer follow‑up visits that include survival assessments at months such as 3 and 6 (and up to 1 year as listed). Participants must sign informed consent and be able to attend treatment and follow‑up visits.
How the study is structured. An interventional, single-group (all participants receive the same treatment) prospective study. Participants receive the modified-DEP drug regimen and are monitored for clinical response and side effects at defined early time points, with survival followed for months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on hemophagocytic lymphohistiocytosis
Important dates
- Study start
- Aug 1, 2024 (estimated)
- Primary completion
- Aug 1, 2026 (estimated)
- Study completion
- Feb 1, 2027 (estimated)
- Target enrollment
- 20 participants (estimated)
- Last updated on registry
- Aug 5, 2024
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Principal investigator
- Xuefeng He, Dr
The First Affiliated Hospital of Soochow University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Xuefeng He, Dr 📞 86-18914031640 ✉ hexuefeng@suda.edu.cn
- Yue Song, Dr 📞 86-18810253070 ✉ xueqifeng1992@163.com
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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