Evaluating eflapegrastim for children with solid tumors or lymphomas undergoing chemotherapy

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 Phase 2, open-label, multicenter study aims to assess the safety and pharmacokinetics of eflapegrastim in pediatric patients aged 1 month to under 17 years who have solid tumors or lymphoma and are receiving myelosuppressive chemotherapy. Approximately 40 participants will be enrolled and divided into four age-based cohorts, with initial focus on dose-limiting toxicities in the first cohort before parallel enrollment in the others. All participants will receive standard chemotherapy followed by subcutaneous administration of eflapegrastim for up to four treatment cycles.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant must have a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement.
2. Participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines.
3. Participant has adequate hematological, renal, and hepatic function.
4. Participant must have an echocardiogram (ECHO) or multigated acquisition (MUGA) within 14 days of Screening if receiving a cardiotoxic therapy and have a cardiac ejection fraction of \>50%.
5. Participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (CNS) involvement within 14 days of study entry.
6. Participant has a Karnofsky performance level ≥50% for patients ≥16 years of age or a Lansky performance level ≥50 for children \<16 years of age.

Exclusion Criteria:

1. Participant has an uncontrollable infection, has an underlying medical condition, and/or another serious illness that would impair the ability of the participant to receive protocol-specified treatment.
2. Participant has had previous exposure to filgrastim (within 7 days), pegfilgrastim (within 14 days), or other granulocyte colony stimulating factor (G-CSF) products in clinical development within 2 weeks prior to the administration of study drug (eflapegrastim)
3. Participant requires concurrent radiation therapy specifically in Cycle 1.
4. Participant has had prior bone marrow or hematopoietic stem cell transplant and/or has concurrent bone marrow involvement in their malignancy, including leukemia.
5. Participant has had spinal radiation therapy within 30 days prior to study enrollment.
6. Participant has used any investigational drugs, biologics or devices within 30 days prior to study treatment or plans to use any of these during the study.
7. Participant has a known sensitivity or previous reactions to any of the G-CSF products.
8. Participant with active CNS disease.
9. Participant has not recovered from previous treatment adverse events to ≤Grade 1.

Where it's running

• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting
• New York Medical College
  Valhalla, New York, United States Terminated
• Carolinas Medical Center/ Levine Children's Hospital
  Charlotte, North Carolina, United States Terminated
• Levine Children's Health
  Charlotte, North Carolina, United States Terminated
• UT MD Anderson Cancer Center
  Houston, Texas, United States Terminated

Study contacts

• Study coordinator: Howard Franklin, MD
• Email: Hfranklin@assertiotx.com
• Phone: 224.419.7106

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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.