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Romiplostim to prevent chemotherapy-induced thrombocytopenia in Ewing sarcoma

This study is looking at whether a drug called romiplostim (AMG-531) can help prevent low platelet counts (chemotherapy-induced thrombocytopenia, or CIT) in children and young adults with newly diagnosed Ewing sarcoma. These patients will be receiving a specific type of chemotherapy. Romiplostim will be given as supportive care, starting early in their treatment. The study wants to see if fewer patients develop CIT compared to past treatments, if romiplostim is safe with chemotherapy, and if patients can receive most of their planned romiplostim doses. You may be able to join if you are over 1 year old, have a new diagnosis of Ewing sarcoma, and are receiving certain chemotherapy regimens.

Study design
This is a single-arm study, meaning all participants will receive the study intervention. It plans to enroll 26 participants.
What's involved
Participants will start romiplostim as early as the first cycle of chemotherapy, or no later than two weeks into the fifth cycle. Romiplostim doses may be adjusted weekly based on platelet counts.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes and adverse events for 52 weeks.

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NCT07048249

Single Arm Romiplostim to Prevent CIT

Recruiting
EARLY_PHASE1Ages 1+InterventionalSupportive care
Children's Hospital Medical Center, Cincinnati
~26 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:Romiplostim (AMG-531)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of evaluable participants (11 or fewer of 26) that develop CIT during the continuation phase of compressed-interval chemotherapy compared to institutional historical control rate.
Measured over 52 weeks
+2 more outcomes measured

Conditions

Ewings Sarcoma
Chemotherapy Induced Thrombocytopenia

Explore related trials

Ewing Sarcoma

Where it's being run

2 sites across 2 states
Arizona1
Ohio1

Study leadership

  • Brian Turpin, DO · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Brian Turpin, DO
[email protected]
513-636-2799
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of evaluable participants (11 or fewer of 26) that develop CIT during the continuation phase of compressed-interval chemotherapy compared to institutional historical control rate.52 weeks

    CIT is defined as 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 (beyond cycle 6)

  • Measure adverse events with the addition of romiplostim when given with chemotherapy.52 weeks

    To determine the safety of incorporation of romiplostim supportive care when given concurrently with Ewing sarcoma therapy.

  • Number of patients able to receive the majority of planned romiplostim doses.52 weeks

    Feasibility will be met if fewer than 9 of 26 enrolled patients fail to receive at least 60% of planned romiplostim doses (excluding doses held for thrombocytosis or post-operatively) from initiation through at least the end of the 13th cycle of chemotherapy or through at least the end of the 16th cycle of chemotherapy.