Thiotepa Incorporating TBI/Cy Conditioning Regimen for EBV-HLH With Central Nervous System Involvement

Not Applicable

Recruiting

• Conditions: HLH
• Interventions: Drug: Thiotepa

• Registration Number: NCT05854225
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

EBV-HLH is the most common in virus-associated hemophagocytic syndrome (VAHS). There are no uniform clinical criteria for the diagnosis of CNS-HLH. And there is still a lack of international consensus on the treatment for CNS-HLH. Following allogeneic HSCT after HLH induction therapy is recommended for CNS-HLH. One of the major factors influencing the transp...

Detailed Description

HLH is an immune disorder characterized by a potentially fatal cytokine storm induced by uncontrolled T lymphocyte and macrophage activation. EBV-HLH is the most common in virus-associated hemophagocytic syndrome (VAHS). There are no uniform clinical criteria for the diagnosis of CNS-HLH. And there is still a lack of international consensus on the treatment ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2023-04-20
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-11
• Last Update Posted: 2023-05-11
• Primary Completion: 2024-06
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Diagnosed as HLH according to HLH-04 diagnostic criteria.
2. a significant increase of EBV-DNA copies/ml in peripheral blood or tissue or EBER(+) in tissue specimens or peripheral blood.
3. Cerebrospinal fluid EBV-DNA ≥5×10^2 copies/ml.
4. Estimated survival time ≥ 1 month.
5. Age 18~60， gender is not limited.
6. Total bilirubin ≤ 2 times the upper limit of normal; serum creatinine ≤ normal value before study entry.
7. Serum HIV antigen or antibody negative.
8. HCV antibody negative.
9. HBsAg negative, HBcAb negative. If any of the above is positive, then HBV-DNA titer in peripheral blood is required less than 1×102 copies/ml before enrollment.
10. Cardiac ultrasound LVEF≥50%.
11. 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.
12. Signed informed consent.

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Exclusion Criteria

1. Heart function above grade II (NYHA).
2. Active bleeding of the internal organs(digestive tract, lung, brain, etc.).
3. Uncontrolled infection (pulmonary infection, intestinal infection, etc.).
4. Severe mental illness.
5. Patients are unable to comply during the trial and/or follow-up phase.
6. Participate in other clinical research at the same time.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-arm	Thiotepa	a prospective single-arm clinical study

Primary Outcome Measures

Name	Time	Method
The clinical remission rate	24 weeks	The number of cases with complete response (CR) and partial response (PR) after transplantation as a percentage of the total cases.

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China