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.
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 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 administration of study drug (eflapegrastim)
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.
Parallel
Eflapegrastim
DrugEflapegrastim supplied in prefilled, single-use syringes for SC injection.
Chemotherapy
DrugChemotherapy agents may include doxorubicin, ifosfamide, docetaxel, CHOP regimen, etoposide, cyclophosphamide and vincristine which will be administered as per standard of care per the Primary Care physician's treatment plan.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Percentage of Participants With Severe Neutropenia in Cycle 1
Severe neutropenia is defined as absolute neutrophil count (ANC) less than 0.5\*10\^9/liter (L).
Time to Absolute Neutrophil Count (ANC) Recovery of Severe Neutropenia in Cycle 1
Time to ANC recovery of severe neutropenia is defined as the time from chemotherapy administration until the participants ANC increases to ≥1.0\*10\^9/L after the expected nadir.
Number of Participants With Febrile Neutropenia in Cycle 1
Febrile neutropenia is defined as ANC less than 0.5\*10\^9/L with a single temperature of \>38.3 degree Celsius (°C) or a sustained temperature of ≥38°C for more than 1 hour.
Peak Concentration (Cmax) of Eflapegrastim in Cycle 1
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