Overview
Prospective interventional randomized controlled trial to assess safety and efficacy of romiplostim in chemotherapy-induced thrombocytopenia in children and adolescents with solid malignancy
Description
Chemotherapy-induced thrombocytopenia (CIT) frequently complicates cancer treatment causing delays in treatment and dose reduction for subsequent administration of cancer-directed treatment.
Romiplostim is a potential agent that can improve platelet counts, allowing the resumption of chemotherapy, decreasing the need for platelet transfusions, and increasing the nadir platelet counts thus improving dose intensity.
Eligibility
Inclusion Criteria:
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 Criteria:
- 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.