Actively Recruiting
A Randomized Controlled Study of High-dose Cyclophosphamide Induction Therapy in Adult Patients With HLH
Led by shifeng Lou · Updated on 2023-08-30
160
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating high-dose cyclophosphamide as an induction therapy for adult secondary hemophagocytic lymphohistiocytosis (HLH), a severe condition involving excessive immune cell activation that can quickly lead to organ damage and early death within 30 days. Secondary HLH arises from tumors, autoimmune diseases, infections, and other causes, and current treatments have high early mortality rates. This study aims to find a more effective induction treatment for non-infective adult HLH by targeting the immune system's overactive T cells. Participants will be randomly assigned to receive either the experimental treatment with high-dose cyclophosphamide or the standard HLH2004 treatment regimen. The cyclophosphamide group will receive 40 mg/kg intravenously once daily for two days. The standard treatment includes drugs such as etoposide, dexamethasone, and cyclosporine administered over several weeks with specified dosing schedules. This design allows comparison of efficacy and safety between the new high-dose therapy and established treatment. During the 30-day study period, participants will be monitored for response to treatment, including complete or near-complete remission rates, partial responses, and mortality. Key measures include fever reduction time and improvements in diagnostic criteria indicators. Safety and treatment effectiveness will be assessed through clinical observations and laboratory tests. Participants will be followed closely to evaluate outcomes and any adverse effects related to the therapies.
CONDITIONS
Brief Title
A Randomized Controlled Study of High-dose Cyclophosphamide Induction Therapy in Adult Patients With HLH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old, any gender
- Diagnosis of HLH based on HLH-2004 criteria, either by molecular diagnosis with known HLH-related mutations or by meeting at least 5 of 8 clinical and laboratory indicators
- Ability to understand the study and provide informed consent
You will not qualify if you...
- HLH caused by treatable infectious agents like bacteria, fungi, or viruses except Epstein-Barr virus
- History of allergy or contraindication to study drugs including cyclophosphamide, etoposide, dexamethasone, or cyclosporine
- Organ damage from long-term chronic diseases
- Extreme physical weakness or unstable vital signs preventing tolerance of high-dose cyclophosphamide
- Severe or uncontrolled other illnesses that pose safety risks or interfere with study compliance
- Mental instability or history of severe mental illness
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive high-dose cyclophosphamide, etoposide, dexamethasone, and cyclosporine as part of the induction therapy for HLH.
Multiple visits over 6 weeks for drug administration and monitoring
Trial Site Locations
Total: 1 location
1
The Second affiliated Hosptial of Chongqing medical University
Chongqing, China
Actively Recruiting
Research Team
S
shifeng Lou, master
J
jianchuan Deng, master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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