Status:
UNKNOWN
Romiplostim in Chemotherapy-Induced Thrombocytopenia
Lead Sponsor:
Ain Shams University
Conditions:
Chemotherapy-induced Thrombocytopenia
Solid Malignancy
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
Prospective interventional randomized controlled trial to assess safety and efficacy of romiplostim in chemotherapy-induced thrombocytopenia in children and adolescents with solid malignancy
Detailed Description
Chemotherapy-induced thrombocytopenia (CIT) frequently complicates cancer treatment causing delays in treatment and dose reduction for subsequent administration of cancer-directed treatment. Romiplos...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients with second primary neoplasm.
- Patients with relapsed/refractory solid malignancy.
- Presence of primary or metastatic liver cancer.
- History of a prior symptomatic venous thromboembolic event (VTE) or arterial ischemic events.
- Patients with thrombocytopenia due to other etiologies e.g., underlying inherited thrombocytopenia.
Key Trial Info
Start Date :
December 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06201663
Start Date
December 17 2023
End Date
December 1 2025
Last Update
January 11 2024
Active Locations (1)
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1
Ain Shams University Children's Hospital
Cairo, Egypt, 11566