OncoMatch/Clinical Trials/NCT07048249
Single Arm Romiplostim to Prevent CIT
Is NCT07048249 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Romiplostim (AMG-531) for ewings sarcoma.
Treatment: Romiplostim (AMG-531) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Prior therapy
Must have received: interval-compressed chemotherapy
treated with interval-compressed chemotherapy as per AEWS0031, AEWS1221, or AEWS1031
Cannot have received: platelet-producing agent (romiplostim, eltrombopag)
Previous use of romiplostim, eltrombopag or any other platelet-producing agent is not allowed.
Cannot have received: therapy for immune thrombocytopenia and related conditions (rituximab, mycophenolic acid, protracted systemic steroids, IVIG)
Previous therapy for immune thrombocytopenia and related conditions, including rituximab, mycophenolic acid, protracted systemic steroids, and/or IVIG, is prohibited.
Cannot have received: erythropoietin-stimulating agent
Treatment with erythropoietin-stimulating agents is prohibited.
Cannot have received: hematopoietic stem cell rescue
Patients requiring hematopoietic stem cell rescue are not eligible.
Cannot have received: investigational drug
Patients receiving another investigational drug are not eligible.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Phoenix Children's · Phoenix, Arizona
- Cincinnati Children's Hospital Medical Center · Cincinnati, Ohio
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