Actively Recruiting
Single Arm Romiplostim to Prevent CIT
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-18
26
Participants Needed
2
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single Arm Romiplostim to Prevent CIT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be older than 1 year at the time of study consent.
- Patients must have a new diagnosis of Ewing sarcoma treated with interval-compressed chemotherapy as per AEWS0031, AEWS1221, or AEWS1031.
- All patients and/or their parents or legal representatives must sign written informed consent. Assent will be obtained when appropriate according to institutional guidelines.
You will not qualify if you...
- Patients with metastatic Ewing sarcoma to the bone marrow are not eligible.
- Patients receiving whole lung radiation, more than 50% pelvic irradiation, or significant bone marrow radiation (50% or more of vertebral marrow space) before cycle 14 are not eligible.
- Patients undergoing pneumonectomy as local control before cycle 14 are not eligible.
- Patients requiring hematopoietic stem cell rescue are excluded.
- Previous use of romiplostim, eltrombopag, or other platelet-producing agents is not allowed.
- Previous treatment for immune thrombocytopenia or related conditions, including rituximab, mycophenolic acid, long-term systemic steroids, or IVIG, is prohibited.
- Treatment with erythropoietin-stimulating agents is prohibited.
- Patients receiving another investigational drug are not eligible.
- Patients on prophylactic heparin or oral anticoagulants may be excluded from certain analyses.
- Patients with a history or current diagnosis of bone marrow failure, hematologic malignancy, pro-thrombotic condition, or platelet disorder are not eligible.
- Patients unable to comply with study safety monitoring are excluded.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Phoenix Children's
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
B
Brian Turpin, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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