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Romiplostim in Chemotherapy-Induced Thrombocytopenia

Safety and Efficacy of Romiplostim in Chemotherapy-Induced Thrombocytopenia in Children and Adolescents With Solid Malignancy

NCT06201663•Ain Shams University

View on ClinicalTrials.gov

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. 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

Age

1 - 18 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Ain Shams University Children's Hospital

Cairo, Egypt

Key Dates

Start Date

December 17, 2023

Primary Completion Date

May 1, 2025

Completion Date

December 1, 2025

Last Updated

January 11, 2024

Enrollment

ESTIMATED participants

Conditions

Chemotherapy-induced ThrombocytopeniaSolid Malignancy

Interventions

Romiplostim

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Romiplostim in Chemotherapy-Induced Thrombocytopenia

Inclusion Criteria

Exclusion Criteria

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

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