Status:
UNKNOWN
SCMC Trial on KHE With KMP (V.2020)
Lead Sponsor:
Shanghai Children's Medical Center
Conditions:
Kaposiform Hemangioendothelioma (KHE) With Kasabach-Merritt Phenomenon (KMP)
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE1
Brief Summary
a phase I trial focusing on safety and efficacy of prednison shock plus sirolimus maintenance in treating Kaposiform hemangioendothelioma (KHE) with Kasabach-Merritt phenomenon (KMP)
Eligibility Criteria
Inclusion
- Kaposiform Hemangioendotheliomas with Kasabach-Merritt Phenomenon
- 0 - 12 years of age at the time of study entry
- Male or female
- Consent of parents (or the person having parental authority in families)
- Signed and dated written informed consent
Exclusion
- with hematological diseases
- with other solid tumors
- with hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney
- dysfunction, and cardiopulmonary insufficiency
- with tuberculosis,cytomegalovirus and Epstein-Barr virus infection before the treatment
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04409691
Start Date
July 1 2020
End Date
June 30 2023
Last Update
June 9 2020
Active Locations (1)
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1
Shanghai Children's Medical Center Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127