SCMC Trial on KHE With KMP (V.2020) (SCMC-KK2020)

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 1

Conditions: Kaposiform Hemangioendothelioma (KHE) With Kasabach-Merritt Phenomenon (KMP)

Treatments: Drug: prednison; Drug: prednison and Sirolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT04409691

SCMC2020

Details and patient eligibility

About

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)

Enrollment: 20 estimated patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

prednison group

Active Comparator group

Treatment:

Drug: prednison

prednison+sirolimus group

Experimental group

Treatment:

Drug: prednison and Sirolimus