Status:
UNKNOWN
Teniposide Incorporating Bu/Cy Conditioning Regimen for HLH With Central Nervous System Involvemen
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
HLH
Eligibility:
All Genders
14-60 years
Phase:
NA
Brief Summary
Hemophagocytic lymphohistiocytosis (HLH) is a highly inflammatory disease involving cytokine storms and is characterised by rapid progression and high mortality. There are no uniform clinical criteria...
Detailed Description
Hemophagocytic lymphohistiocytosis (HLH) is a highly inflammatory disease involving cytokine storms and is characterised by rapid progression and high mortality. HLH with central nervous system involv...
Eligibility Criteria
Inclusion
- Diagnosed as HLH according to HLH-04 diagnostic criteria.
- The indications for the presence of allogeneic hematopoietic stem cell transplantation (allo HSCT) include: I. Primary HLH; II. Refractory/recurrent HLH; III. Severe CNS-HLH.
- According to the different causes of HLH, meeting the following conditions is defined as CNS-HLH.
- I. Definition of CNS-HLH in EBV-HLH: a significant increase of EBV-DNA copies/ml in peripheral blood or tissue or EBER(+) in tissue specimens or peripheral blood. Meanwhile cerebrospinal fluid EBV-DNA ≥5×10\^2 copies/ml.
- II.Definition of CNS-HLH in primary HLH: Nervous system symptom/sign or cerebrospinal fluid cell increase (\> 5 cells/μ L) and/or cerebrospinal fluid protein abnormality (\> 35mg/dL) and/or brain parenchyma or meningeal abnormality in cranial imaging during the onset or course of HLH.
- III. Definition of CNS-HLH of lymphoma-associated HLH: Cerebrospinal fluid flow cytology or brain histopathology confirmed that lymphoma involved CNS. Cerebrospinal fluid EBV-DNA ≥5×10\^2 copies/ml are also defined as CNS-HLH for EBV positive lymphoma-associated HLH.
- Estimated survival time ≥ 1 month.
- Age 14\~60# gender is not limited.
- Total bilirubin ≤ 2 times the upper limit of normal; serum creatinine ≤normal value before study entry.
- Serum HIV antigen or antibody negative.
- HCV antibody negative.
- HBsAg negative, HBcAb negative. If any of the above is positive, then HBV-DNA titer in peripheral blood is required less than 1×10\^2 copies/mL before enrollment.
- Cardiac ultrasound LVEF≥50%.
- Women in the child-bearing period must not be pregnant as determined by a pregnancy test and must be willing to use effective contraception during the trial and for ≥ 12 months after the last dose. Pregnant and lactating women cannot participate. All male subjects accept contraception during the trial and for ≥6 months after the last dose.
- Signed informed consent.
Exclusion
- Heart function above grade II (NYHA).
- Active bleeding of the internal organs(digestive tract, lung, brain, etc.).
- Uncontrolled infection (pulmonary infection, intestinal infection, etc.).
- Severe mental illness.
- Patients are unable to comply during the trial and/or follow-up phase.
- Participate in other clinical research at the same time.
Key Trial Info
Start Date :
October 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06048107
Start Date
October 22 2023
End Date
September 30 2025
Last Update
November 2 2023
Active Locations (1)
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1
Zhao Wang
Beijing, China, 100050, China