Romiplostim in Chemotherapy-Induced Thrombocytopenia

Chemotherapy-induced Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201663
• Other study ID #: FAMSU MD343/2023
• Status: Recruiting
• Phase: Phase 3
• Start date: December 17, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Thrombocytopenia
• Neoplasms
• Solid Malignancy
• Thrombocytopenia

Intervention

Drug:
• Romiplostim
Weekly subcutaneous injections

Locations

Country	Name	City	State
Egypt	Ain Shams University Children's Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologic response	Platelet count increase to > 75 x 10e9/L, as well as toleration of chemotherapy resumption for at least 8 weeks or two cycles without subsequent chemotherapy dose reduction or dose delay because of recurrent CIT	12 weeks