NCT07048249

Single Arm Romiplostim to Prevent CIT

Single Arm Evaluation of Romiplostim to Prevent Chemotherapy Induced Thrombocytopenia in Patients With Ewing Sarcoma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to to assess the efficacy of romiplostim as a supportive care measure in patients with a new diagnosis of Ewing sarcoma receiving interval-compressed chemotherapy. The main questions it aims to answer are: 1. To demonstrate the efficacy of romiplostim in patients with newly diagnosed Ewing sarcoma, measured specifically as the rate of CIT, defined as a failure to achieve platelet recovery (≥ 75,000/µL post nadir, without transfusion, or a platelet count sufficient to resume chemotherapy per provider and institutional standard) within 7 days of planned chemotherapy cycle start, measured during the continuation phase (cycle 7 to end of cycle 13 or 16, per AEWS0031/AEWS1221, or AEWS1031 respectively) of interval-compressed chemotherapy (every 2 week vincristine/cyclophosphamide +/- doxorubicin and ifosfamide/etoposide chemotherapy) as compared to published institutional historical control rate. 2. To determine the safety of incorporation of romiplostim supportive care when given concurrently with Ewing sarcoma therapy. 3. To determine the feasibility of incorporation of romiplostim supportive care into upfront Ewing sarcoma regimens.

Detailed description

This is a single-arm, multi-center clinical trial to assess the efficacy of romiplostim as a supportive care measure in patients with a new diagnosis of Ewing sarcoma receiving interval-compressed chemotherapy. Patients will be enrolled and started on romiplostim as early as cycle 1 day 1 of their chemotherapy, but no later than 2 weeks from the start of the 5th cycle. If their platelet count is \< 200,000/mm3, patients will start romiplostim based on their weight. Dose escalation of romiplostim may occur weekly if platelet count is \< 200,000/mm3. Once maximum dose of romiplostim is reached, this dose level will be maintained every 7 days (+/- 2 days).

Conditions

• Ewings Sarcoma
• Chemotherapy Induced Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Romiplostim (AMG-531)	Romiplostim may be started as supportive care, as early as cycle 1 day 1; all patients MUST initiate romiplostim no later than 2 weeks from the start of the 5th cycle of chemotherapy (see exception below for patients with platelet count of 200,000 or greater). If plt count \< 200,000/mm3, patients will start romiplostim based on their weight

Timeline

• Start date: 2024-01-26
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-07-02
• Last updated: 2026-03-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study