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 2026-10-28.
Sponsored by Spectrum Pharmaceuticals, Inc (part of Zydus Lifesciences Limited) · 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.
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's planned enrollment of 40 is close to the median of 43 across 2,319 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Spectrum Pharmaceuticals, Inc is the lead sponsor of 60 studies on the registry; 1 is open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 12 (67%) have results posted.
First submitted before Spectrum Pharmaceuticals, Inc became part of Zydus Lifesciences Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Eflapegrastim
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