Safety and Efficacy of Romiplostim in Chemotherapy-Induced Thrombocytopenia in Children and Adolescents With Solid Malignancy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Prospective interventional randomized controlled trial to assess safety and efficacy of romiplostim in chemotherapy-induced thrombocytopenia in children and adolescents with solid malignancy
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
View:
⁃ Age: 1- 18 years. Patients diagnosed with solid malignancy based on clinical, histopathological features, and /or immunohistochemical staining.
⁃ Patients with chemotherapy-induced thrombocytopenia defined as either
• severe thrombocytopenia either clinically with high bleeding score or laboratory by platelet count reaching critical level \< 20x10e9/L requiring platelet transfusion at time of chemotherapy cycle nadir.
• delayed recovery of platelet count: a platelet count of less than 100 x10e9/L for 3 weeks from the first day of chemotherapy cycle administration or the previous dose was reduced by \>20% due to low platelet count \<100×10e9/L.
Locations
Other Locations
Egypt
Ain Shams University Children's Hospital
RECRUITING
Cairo
Time Frame
Start Date:2023-12-17
Estimated Completion Date:2025-12
Participants
Target number of participants:30
Treatments
Experimental: Interventional group
Patients with CIT fulfilling the inclusion criteria will receive romiplostim subcutaneously weekly, either at the time of nadir of a delayed chemotherapy cycle or on the first day of the subsequent chemotherapy cycle and continue until the completion of chemotherapy for maximum 12 weeks.~Starting dose will be 3 μg/kg with the escalation of the dose weekly by 2 μg/kg (maximum dose 10 μg/kg) when the platelet increment was less than 25 x10e9/L to maintain platelet counts above 75x10e9/L.
No_intervention: Control group
Patients with CIT fulfilling the inclusion criteria randomized to the control group will not receive romiplostim injections.~Patients are allowed to received supportive care according to the standard of care protocols.