Using romiplostim to treat low platelet counts in children with cancer receiving chemotherapy
Safety and Efficacy of Romiplostim in Chemotherapy-Induced Thrombocytopenia in Children and Adolescents With Solid Malignancy
This study is testing if a drug called romiplostim can help children with cancer who have low platelet counts from chemotherapy so they can keep getting their treatment without interruptions.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06201663 on ClinicalTrials.gov |
What this trial studies
This interventional trial aims to evaluate the safety and effectiveness of romiplostim in children and adolescents aged 1 to 18 years who experience chemotherapy-induced thrombocytopenia (CIT) due to solid malignancies. The study will involve a randomized controlled design to assess how well romiplostim can improve platelet counts, thereby allowing patients to continue their chemotherapy without delays or dose reductions. By potentially reducing the need for platelet transfusions and enhancing the intensity of cancer treatment, this trial seeks to improve overall treatment outcomes for young cancer patients.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 1-18 years diagnosed with solid malignancies who are experiencing chemotherapy-induced thrombocytopenia.
Not a fit: Patients with second primary neoplasms, relapsed/refractory solid malignancies, or thrombocytopenia from other causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help maintain chemotherapy regimens for children with cancer by preventing severe low platelet counts.
How similar studies have performed: While the use of romiplostim in this specific population is novel, similar approaches in managing thrombocytopenia have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo
- Ain Shams University Children's Hospital — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.