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Oral Prednisone in Treating LCH of Bone in Childhood and Adolescence

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Nov 1, 2023 to Nov 4, 2023v3
  2. Start date: Oct 1, 2023 to Nov 1, 2023v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Langerhans cell histiocytosis (LCH) of bone is a benign-tumor-like osteolytic lesion in childhood and adolescence, which is characterized by the aberrant activation of antigen presenting cells. Rather than the multi-system involvements of LCH, no standard or widely-accepted therapeutic regimens were established for LCH of bone. In the previous clinical practice, several LCH patients obtained remarkable pain relief after taking prednisone. Therefore, the investigators aim to conducting a multi-center, open-labelled, randomized-controlled, Phase II study to investigate the efficacy and safety of oral prednisone in treating LCH of bone in children and adolescents. The enrolled patients will be randomly recruited to the following groups: (1) Oral prednisone \[Test group); (2) Regular observation \[Control group\].
Trial Details
NCT Number NCT06078969
Lead Sponsor Shanghai Changzheng Hospital
Collaborators: First Affiliated Hospital of Zhejiang University, Peking University Third Hospital, National Sun Yat-sen University, Beijing Children's Hospital, Henan Cancer Hospital, Tianjin Hospital, First Affiliated Hospital, Sun Yat-Sen University, Second Hospital of Jilin University, Peking University People's Hospital, Jinling Hospital, China, The First Affiliated Hospital of Nanchang University, The Third Affiliated Hospital of Southern Medical University
Conditions
(from sponsor)		 Langerhans Cell Histiocytosis of Bone
Related terms Histiocytosis, Langerhans-Cell
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov