Hemophagocytic LymphohistiocytosesPhase 4NCT06504030
Modified DEP Regimens for the Treatment of Hemophagocytic Lymphohistiocytosis
A Phase 4 study testing modified-DEP in people with Hemophagocytic Lymphohistiocytoses, run by The First Affiliated Hospital of Soochow University.
Trial summary
This study is trying to evaluate the efficacy and safety of modified DEP regimens for the treatment of active hemophagocytic lymphohistiocytosis. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Hemophagocytic Lymphohistiocytoses
- What is being tested?
- modified-DEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm, Single-center, Prospective Study of Modified DEP Regimens (Doxorubicin+ Etoposide + Methylprednisolone) for the Treatment of Hemophagocytic Lymphohistiocytosis
This study is trying to evaluate the efficacy and safety of modified DEP regimens for the treatment of active hemophagocytic lymphohistiocytosis.
Read the 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 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.
- Conditions
- Hemophagocytic Lymphohistiocytoses
- Being tested
- modified-DEP
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified-DEPDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| modified-DEP for HLH | Experimental | modified-DEP for the treatment of non-EBV-HLH and EBV-HLH patients. Receives: Drug: modified-DEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of modified-DEP
Rates of complete response, partial response, improvement
Measured: 2 weeks, 4 weeks, 6 weeks, 8 weeks
Incidence of Treatment-Emergent Adverse Events
Rates of adverse events
Measured: 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary outcomes (1)
Survival of patients
The disease outcomes, 3-month and 6-month survival rates, and median survival
Measured: 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophagocytic LymphohistiocytosesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuefeng He, The First Affiliated Hospital of Soochow University
- Investigators
- Xuefeng He, Dr, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504030
- Sponsor's protocol ID
- modified-DEP
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center, Prospective Study of Modified DEP Regimens (Doxorubicin+ Etoposide + Methylprednisolone) for the Treatment of Hemophagocytic Lymphohistiocytosis
- ClinicalTrials.gov ID
- NCT06504030
- Acronym / sponsor ID
- modified-DEP
- Conditions
- Hemophagocytic Lymphohistiocytoses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| modified-DEP for HLH | Experimental | Drug: modified-DEPmodified-DEP for the treatment of non-EBV-HLH and EBV-HLH patients. |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified-DEPFor 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. | Drug | modified-DEP for HLH |
Primary outcome
Response rate of modified-DEP
Time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks
Rates of complete response, partial response, improvement
Incidence of Treatment-Emergent Adverse Events
Time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks
Rates of adverse events
1 secondary outcome
Survival of patients
Time frame: 3 months, 6 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Hemophagocytic Lymphohistiocytoses
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Not yet recruitingObservational study
Long Term Safety Study in Patients With HLH/MAS in Still's Disease Exposed to Gamifant.
Hemophagocytic Lymphohistiocytosis (HLH), Macrophage Activation Syndrome (MAS)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis After Allogeneic Stem Cell Transplantation
Hemophagocytic Lymphohistiocytosis (HLH)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xuefeng He, Dr principal investigator
The First Affiliated Hospital of Soochow University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing modified-DEP in people with Hemophagocytic Lymphohistiocytoses, run by The First Affiliated Hospital of Soochow University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuefeng He, Dr (86-18914031640, hexuefeng@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate of modified-DEP (time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.