Romiplostim in Chemotherapy-Induced Thrombocytopenia

Ain Shams University

Status and phase: Enrolling; Phase 3

Conditions: Chemotherapy-induced Thrombocytopenia; Solid Malignancy

Treatments: Drug: Romiplostim

Study type: Interventional

Funder types: Other

Identifiers

NCT06201663

FAMSU MD343/2023

Details and patient eligibility

About

Prospective interventional randomized controlled trial to assess safety and efficacy of romiplostim in chemotherapy-induced thrombocytopenia in children and adolescents with solid malignancy

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Interventional group

Experimental group

Description:

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.

Treatment:

Drug: Romiplostim

Control group

No Intervention group

Description:

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.