A Phase 2 interventional study of Eflapegrastim and Chemotherapy in Solid Tumors and Lymphoma, sponsored by Spectrum Pharmaceuticals, Inc. Recruiting at 5 sites in United States. Open to participants aged 1 Month to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Spectrum Pharmaceuticals, Inc · Phase 2, Interventional, and Treatment
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.
This is a Phase 2, open label, multicenter study of eflapegrastim in pediatric participants (≥1 month to \<17 years) with solid tumors or lymphoma.
Approximately 40 participants will be enrolled and assigned to one of 4 age-based cohorts. Participants enrolled in Cohort 1 will be followed for dose-limiting toxicities (DLTs) prior to initiating parallel enrollment into Cohorts 2 through 4.
All participants will receive chemotherapy as Standard of Care after which a subcutaneous (SC) dose of eflapegrastim will be administered up to 4 treatment cycles.
Exclusion Criteria:
Participants will receive a SC injection of eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected).
Drug: Eflapegrastim · Drug: Chemotherapy
Participants will receive a SC injection eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected).
Drug: Eflapegrastim · Drug: Chemotherapy
Participants will receive a SC injection eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected).
Drug: Eflapegrastim · Drug: Chemotherapy
Participants will receive a SC injection eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected).
Drug: Eflapegrastim · Drug: Chemotherapy
Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
Also known as: Rolontis®, SPI-2012
Chemotherapy 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.
Time frame: From first dose of study drug to 35 days after the last dose of the study drug (Up to approximately 16 months)
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 frame: Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)
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.
Time frame: Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)
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.
Time frame: Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)
Peak Concentration (Cmax) of Eflapegrastim in Cycle 1
Time frame: Pre-dose and at multiple time points (up to Day 9 [Cohorts 1-3] and Day 6 [Cohort 4]) post-dose in Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)
Time to Reach Peak Concentration (Tmax) of Eflapegrastim in Cycle 1
Time frame: Pre-dose and at multiple time points (up to Day 9 [Cohorts 1-3] and Day 6 [Cohort 4]) post-dose in Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)
Elimination Half-life (t½) of Eflapegrastim in Cycle 1
Time frame: Pre-dose and at multiple time points (up to Day 9 [Cohorts 1-3] and Day 6 [Cohort 4]) post-dose in Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)
Plan to share: No
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Spectrum Pharmaceuticals, Inc