A Study of Eflapegrastim in Children with Solid Tumors or Lymphoma
This study is looking at the safety of a drug called eflapegrastim in children and teenagers (ages 1 month to 17 years old) who have solid tumors or lymphoma. These participants will also be receiving chemotherapy, which can sometimes lower the number of certain blood cells. Eflapegrastim is given as an injection under the skin. The main goal is to see how many participants experience side effects from the treatment. About 40 participants will join this study, which is currently recruiting.
- Study design
- This is an open-label study, meaning everyone knows which treatment is being given. It will include about 40 participants divided into age groups.
- What's involved
- Participants will receive chemotherapy as part of their standard care, followed by up to four cycles of eflapegrastim injections. The study will monitor participants for side effects for about 16 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for side effects from the first dose of eflapegrastim until 35 days after their last dose, which could be up to approximately 16 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
At a glance
Conditions
NCT04570423
Where you'd take part
This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University Hospitals Cleveland Medical Center
Cleveland, Ohiono site contact published
Recruiting
Carolinas Medical Center/ Levine Children's Hospital
Charlotte, North Carolinano site contact published
Terminated
Levine Children's Health
Charlotte, North Carolinano site contact published
Terminated
New York Medical College
Valhalla, New Yorkno site contact published
Terminated
UT MD Anderson Cancer Center
Houston, Texasno site contact published
Terminated
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)From first dose of study drug to 35 days after the last dose of the study drug (Up to approximately 16 months)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is any AE that occurs from the first dose of the study drug until 35 days after the last dose of study drug, or on the day a new/additional chemotherapy regimen, or on the day another granulocyte-colony stimulating factor (G-CSF) is administered.