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Tests treatment safety and results for Solid Tumors
Official title A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
ClinicalTrials.gov ID: NCT04570423
What this study is testing
What is Eflapegrastim?
Eflapegrastim is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for solid tumors.
Also referred to as Rolontis®, SPI-2012.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphoma and treated with myelosuppressive chemotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- Participant must have a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement.
- Participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National...
- Participant has adequate hematological, renal, and hepatic function.
- Participant must have an echocardiogram (ECHO) or multigated acquisition (MUGA) within 14 days of Screening if receiving a cardiotoxic therapy and...
- Participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (CNS) involvement within 14 days of study entry.
You likely can't join if
- Participant has an uncontrollable infection, has an underlying medical condition, and/or another serious illness that would impair the ability of the...
- Participant has had previous exposure to filgrastim (within 7 days), pegfilgrastim (within 14 days), or other granulocyte colony stimulating factor...
- Participant requires concurrent radiation therapy specifically in Cycle 1.
- Participant has had prior bone marrow or hematopoietic stem cell transplant and/or has concurrent bone marrow involvement in their malignancy...
- Participant has had spinal radiation therapy within 30 days prior to study enrollment.
- 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...
See the full eligibility criteria
- Participant must have a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement.
- 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.
- Participant has adequate hematological, renal, and hepatic function.
- 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%.
- Participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (CNS) involvement within 14 days of study entry.
- 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.
- 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.
- 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...
- Participant requires concurrent radiation therapy specifically in Cycle 1.
- Participant has had prior bone marrow or hematopoietic stem cell transplant and/or has concurrent bone marrow involvement in their malignancy, including leukemia.
- Participant has had spinal radiation therapy within 30 days prior to study enrollment.
- 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.
- Participant has a known sensitivity or previous reactions to any of the G-CSF products.
- Participant with active CNS disease.
- Participant has not recovered from previous treatment adverse events to ≤Grade 1.
The study team makes the final eligibility decision.
Where it's taking place
- Valhalla, New York, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valhalla, New York, United States; Charlotte, North Carolina, United States; Cleveland, Ohio, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.