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RecruitingNCT05854225Updated May 11, 2023

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

An interventional study of Thiotepa in HLH, sponsored by Beijing Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by Beijing Friendship Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2022, registered Apr 2023).
  • Started Jan 2022; still recruiting 4 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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 transplantation effect is conditioning. Therefore, we conduct a prospective clinical study to explore the efficacy and safety of thiotepa incorporating TBI/Cy conditioning regimen followed by allogeneic hematopoietic stem cell transplantation for EBV-HLH with central nervous system involvement.

Read the 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 for CNS-HLH. CNS involvement is one of the factors in the poor prognosis for HLH. Following allogeneic HSCT after HLH induction therapy is recommended for CNS-HLH. One of the major factors influencing the transplantation effect is conditioning. Therefore, we conduct a prospective clinical study to explore the efficacy and safety of thiotepa incorporating TBI/Cy conditioning regimen followed by allogeneic hematopoietic stem cell transplantation for EBV-HLH with central nervous system involvement.

02

Conditions studied

  • HLH
03

In context

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    single-arm

    a prospective single-arm clinical study

    Drug: Thiotepa

Interventions

  • DrugThiotepa

    Thiotepa is an alkylating agent that is routinely used in solid tumors, but it is able to cross the blood-brain barrier into the center.

    Also known as: TT

06

What researchers measure

Primary outcomes

  1. The clinical remission rate

    The number of cases with complete response (CR) and partial response (PR) after transplantation as a percentage of the total cases.

    Time frame: 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing 100050, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05854225
Lead sponsor
Beijing Friendship Hospital
Responsible party
Zhao Wang (Professor and Head of hematology, Beijing Friendship Hospital) — Principal investigator
First posted
May 11, 2023
Start date
Jan 1, 2022
Primary completion
Jun 2024 (estimated)
Completion
Jan 2025 (estimated)
Last update
May 11, 2023

Study contacts

wang zhao, MD
Contact
wangzhao@ccmu.edu.cn
63138303
wang zhao, MD
principal investigator · Beijing Friendship Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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