Single Arm Romiplostim to Prevent CIT

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called romiplostim can help prevent low platelet counts (a condition called thrombocytopenia) caused by chemotherapy in patients newly diagnosed with Ewing sarcoma, a type of cancer. Platelets are blood cells that help with clotting, and having too few can increase the risk of bleeding. The study aims to see if romiplostim is safe and effective when given alongside the usual chemotherapy treatment, and whether it can be easily added to the treatment plan.

Patients who are eligible for this study are those over 1 year old with a new diagnosis of Ewing sarcoma who will receive a specific type of chemotherapy. Some patients, such as those with cancer spread to the bone marrow or those receiving certain types of radiation or other treatments, may not qualify. If enrolled, participants will receive romiplostim during their chemotherapy and will be closely monitored for safety and how well their platelet counts recover. This trial is currently recruiting patients and is open to all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: Patients must be \>1 year old at the time of study consent.
• • Diagnosis: Patients with a new diagnosis of Ewing sarcoma treated with interval-compressed chemotherapy as per AEWS0031, AEWS1221, or AEWS1031.
• • Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
• Exclusion Criteria:
• • Marrow disease: Patients with metastatic Ewing sarcoma to the bone marrow are not eligible. Marrow staging is not required for this study but should be performed if clinically indicated.
• • Concomitant therapy, cancer directed: Patients receiving whole lung radiation, \>50% of pelvic irradiation, other substantial bone marrow radiation (i.e. ≥ 50% of vertebral marrow space), or patients undergoing pneumonectomy as a component of local control before cycle 14, are not eligible. These therapies are not an exclusion if instituted during or after cycle 14.
• * Concomitant therapy, non-cancer directed:
• • Patients requiring hematopoietic stem cell rescue are not eligible.
• • Previous use of romiplostim, eltrombopag or any other platelet-producing agent is not allowed.
• • Previous therapy for immune thrombocytopenia and related conditions, including rituximab, mycophenolic acid, protracted systemic steroids, and/or IVIG, is prohibited.
• • Treatment with erythropoietin-stimulating agents is prohibited.
• • Patients receiving another investigational drug are not eligible.
• • Patients who are receiving prophylactic dosing of heparin (i.e. enoxaparin) or oral anticoagulants (i.e. rivaroxaban) for thrombosis prevention may be considered for enrollment but will be excluded from secondary aim 'a' analysis (efficacy measured as the median platelet count and transfusion dependency) given shift in transfusion thresholds.
• • Concurrent Illnesses: Patients with a history of or current diagnosis of bone marrow failure, hematologic malignancy, pro-thrombotic condition, or platelet disorder (including immune or heparin induced thrombocytopenia) are not eligible.
• • Patients who in the opinion of the investigator may not be able to comply with the study (including safety monitoring requirements of the study) are not eligible.