Romiplostim in Chemotherapy-Induced Thrombocytopenia

NCT06201663 | Unknown Phase 3

• 1 other identifier: FAMSU MD343/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Chemotherapy-induced Thrombocytopenia; Solid Malignancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Interventional group

EXPERIMENTAL

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.

Drug: Romiplostim

Control group

NO INTERVENTION

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.

Interventions

Romiplostim DRUG

Weekly subcutaneous injections

Also known as: TPO-RA

Interventional group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Children's Hospital

Cairo, 11566, Egypt

RECRUITING

MeSH Terms

Interventions

romiplostim

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: December 17, 2023
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 11, 2024

Record last verified: 2023-12

Locations

EG (1)