RecruitingEarly Phase 1NCT07048249

Single Arm Romiplostim to Prevent CIT

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


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

26 participants

Start Date

Jan 26, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This study is testing romiplostim — a drug that stimulates platelet production — to prevent chemotherapy-induced thrombocytopenia (dangerously low platelet counts) in children and young people being treated for Ewing sarcoma (a type of bone cancer) with intensive chemotherapy. Low platelets during chemotherapy can cause dangerous bleeding and require blood transfusions. **You may be eligible if...** - You (or your child) are over 1 year old with a new diagnosis of Ewing sarcoma - You are being treated with interval-compressed chemotherapy per standard Ewing sarcoma protocols (AEWS0031, AEWS1221, or AEWS1031) - A parent, guardian, or patient has signed informed consent **You may NOT be eligible if...** - The cancer has spread to the bone marrow - You are receiving or plan to receive whole lung radiation, extensive pelvic radiation, or pneumonectomy before cycle 14 of chemotherapy - You have previously used romiplostim, eltrombopag, or similar platelet-boosting drugs - You have a history of a platelet disorder, blood clotting disorder, or bone marrow failure - You are receiving another experimental drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRomiplostim (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


Locations(2)

Phoenix Children's

Phoenix, Arizona, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

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NCT07048249


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