Romiplostim to prevent chemotherapy-related low platelets in Ewing sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, multi-center trial giving romiplostim (Nplate) to patients with newly diagnosed Ewing sarcoma who are receiving interval-compressed chemotherapy. Participants start romiplostim as early as cycle 1 day 1 or no later than two weeks after the start of cycle 5, with dosing based on weight and weekly escalation if platelet counts remain below 200,000/µL. The main outcome is the rate of chemotherapy-induced thrombocytopenia (failure to achieve platelet recovery by the planned cycle start) during the continuation phase, compared to published historical controls, and safety of the drug will also be monitored. Treatment is delivered at participating pediatric oncology centers with regular platelet monitoring and dose adjustments as needed.

Why it matters

Who can join: the full rules

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.

Where it's running

• Phoenix Children's
  Phoenix, Arizona, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Brian Turpin, DO — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Brian Turpin, DO
• Email: cancer@cchmc.org
• Phone: 513-636-2799

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Romiplostim N01 to treat chemotherapy-related low platelets

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• Romiplostim N01 for chemotherapy-related low platelets in children and young adults

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• Using Herombopag to treat low platelet counts from chemotherapy

  This study is testing if a new medication called Herombopag can help increase low platelet counts in patients who have not responded well to other treatments after chemotherapy.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT05236582

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.