- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06048107
Teniposide Incorporating Bu/Cy Conditioning Regimen for HLH With Central Nervous System Involvemen
Teniposide Incorporating Bu/Cy Conditioning Regimen Followed by HSCT for HLH With Central Nervous System Involvement: a Prospective Single-arm Clinical Study
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhao Wang
- Phone Number: 010-80838339
- Email: wangzhao@ccmu.edu.cn
Study Locations
-
-
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Beijing, China, 100050, China
- Recruiting
- Zhao Wang
-
Contact:
- Zhao Wang
- Phone Number: 01080838339
- Email: wangzhao@ccmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: a prospective single-arm clinical study
|
Teniposide is semisynthetic analogues of podophyllotoxin, and they are used in the treatment of leukemia, lymphoma, and certain sorts of solid tumors.In addition, tiniposide has central permeability and is commonly used in the treatment of central nervous system tumors.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The clinical remission rate
Time Frame: 24 weeks
|
The number of cases with complete response (CR) and partial response (PR) after ransplantation as a percentage of the total cases.
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zhao Wang, Department of Hematology, Affiliated Beijing Friendship Hospital, Capital Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BFH20230727002/BFHHZS20230169
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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