Romiplostim in Chemotherapy-Induced Thrombocytopenia

NCT ID: NCT06201663

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-17
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Chemotherapy-induced Thrombocytopenia; Solid Malignancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interventional group

Patients with CIT fulfilling the inclusion criteria will receive romiplostim subcutaneously weekly, either at the time of nadir of a delayed chemotherapy cycle or on the first day of the subsequent chemotherapy cycle and continue until the completion of chemotherapy for maximum 12 weeks.

Starting dose will be 3 μg/kg with the escalation of the dose weekly by 2 μg/kg (maximum dose 10 μg/kg) when the platelet increment was less than 25 x10e9/L to maintain platelet counts above 75x10e9/L.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: DRUG

Weekly subcutaneous injections

Control group

Patients with CIT fulfilling the inclusion criteria randomized to the control group will not receive romiplostim injections.

Patients are allowed to received supportive care according to the standard of care protocols.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Romiplostim

Weekly subcutaneous injections

Intervention Type: DRUG

Other Intervention Names

TPO-RA

Eligibility 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain Shams University Children's Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Sara S Makkeyah, PhD

Role: primary

smakkeyah@med.asu.edu.eg

+201140105222

Reem M El-Mazloom, MSc

Role: backup

reem.mazloom@med.asu.edu.eg

+201002488174

Other Identifiers

FAMSU MD343/2023

Identifier Type: -

Identifier Source: org_study_id