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New treatment option for Hemophagocytic Syndrome
Official title A Randomized Controlled Study of High-dose Cyclophosphamide Induction Therapy in Adult Patients With HLH
ClinicalTrials.gov ID: NCT05936086
What this study is testing
What is Cytoxan?
Cytoxan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hemophagocytic syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Adult secondary HLH involves tumors, autoimmune diseases and other causes in addition to infection,Infectious factors, theoretically need different treatment methods for different etiology. But adult HLH itself disease .The situation progresses ferociously, which can cause organ damage and blood coagulation disorder and endanger life quickly, with early mortality (30days).It can be more than 50%.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Age range from 18 to 65 years old (including the critical value), gender is not limited;
- According to the diagnostic criteria of HLH-2004, HLH can be diagnosed if any of the following two criteria are met:
- Molecular diagnosis is consistent with HLH: Currently known HLH related pathogenic genes exist, such as PRF1, UNC13D, STX11, STXBP2, Rab27a, LYST...
- Meet 5 or more of the following 8 indicators:
- Fever: body temperature \> 38.5 ℃, continuous \> 7 d; ② Splenomegaly;
You likely can't join if
- HLH caused by treatable infectious causes (such as bacteria, fungi, viruses (except Epstein-Barr virus), protozoa, etc.);
- Have a history of allergy or contraindications to the drugs involved in the program;
- Organ damage caused by long-term chronic diseases;
- Extreme physical weakness, unstable vital signs and inability to tolerate large doses of cyclophosphamide;
- Severe and/or uncontrolled co-morbidivities (e.g., uncontrolled diabetes, pulmonary hypertension, etc.) that the investigator believes may pose an...
- Mental instability or history of severe mental illness
See the full eligibility criteria
- Age range from 18 to 65 years old (including the critical value), gender is not limited;
- According to the diagnostic criteria of HLH-2004, HLH can be diagnosed if any of the following two criteria are met:
- Molecular diagnosis is consistent with HLH: Currently known HLH related pathogenic genes exist, such as PRF1, UNC13D, STX11, STXBP2, Rab27a, LYST, SH2D1A, BIRC4, ITK, AP3β1, MAGT1, CD27 (cluster of differentiation...
- Meet 5 or more of the following 8 indicators:
- Fever: body temperature \> 38.5 ℃, continuous \> 7 d; ② Splenomegaly;
- Hemocytopenia (involving two or three peripheral blood lines) : hemoglobin \ 3 mmol/L or 3 standard deviations above the same age, fibrinogen \< 1.5g /L or less than 3 standard deviations for the same age; (5)...
- The activity of NK cells is decreased or absent; ⑦ Serum ferritin increase: ferritin ≥500 μg/L; Elevated sCD25 (soluble interleukin-2 receptor). (3) Those who can understand the research content, agree to comply with...
- HLH caused by treatable infectious causes (such as bacteria, fungi, viruses (except Epstein-Barr virus), protozoa, etc.);
- Have a history of allergy or contraindications to the drugs involved in the program;
- Organ damage caused by long-term chronic diseases;
- Extreme physical weakness, unstable vital signs and inability to tolerate large doses of cyclophosphamide;
- Severe and/or uncontrolled co-morbidivities (e.g., uncontrolled diabetes, pulmonary hypertension, etc.) that the investigator believes may pose an unacceptable safety risk or interfere with protocol compliance;
- Mental instability or history of severe mental illness
- Other factors determined by the researcher that people are not suitable to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.