Solid TumorsPhase 2NCT04570423
A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
A Phase 2 study testing Eflapegrastim and Chemotherapy in people with Solid Tumors and Lymphoma, run by Spectrum Pharmaceuticals, Inc at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Solid Tumors, Lymphoma
- What is being tested?
- Eflapegrastim and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 May 2021to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 1 recruiting
- Terminated
Carolinas Medical Center/ Levine Children's Hospital
Charlotte, North Carolina, 28203
- Terminated
Levine Children's Health
Charlotte, North Carolina, 28203
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Terminated
UT MD Anderson Cancer Center
Houston, Texas, 77030
- Terminated
New York Medical College
Valhalla, New York, 10595
About this study
Official title: A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
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.
Read the detailed description
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.
- Conditions
- Solid Tumors, Lymphoma
- Being tested
- Eflapegrastim, Chemotherapy
- Keywords
- Lymphomas, Solid Tumors, Chemotherapy
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EflapegrastimDrug
Also called Rolontis®, SPI-2012
Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: ≥12 to <17 years | Experimental | 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). Receives: Drug: Eflapegrastim; Drug: Chemotherapy |
| Cohort 2: ≥6 to <12 years | Experimental | 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). Receives: Drug: Eflapegrastim; Drug: Chemotherapy |
| Cohort 3: ≥2 to <6 years | Experimental | 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). Receives: Drug: Eflapegrastim; Drug: Chemotherapy |
| Cohort 4: ≥1 month to <2 years | Experimental | 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). Receives: Drug: Eflapegrastim; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose of study drug to 35 days after the last dose of the study drug (Up to approximately 16 months)
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start20 May 2021
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570423
- Sponsor's protocol ID
- SPI-GCF-202
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2020
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
- ClinicalTrials.gov ID
- NCT04570423
- Acronym / sponsor ID
- SPI-GCF-202
- Conditions
- Solid Tumors, Lymphoma
- Keywords
- Lymphomas, Solid Tumors, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: ≥12 to <17 years | Experimental | Drug: Eflapegrastim, Drug: ChemotherapyParticipants 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). |
| Cohort 2: ≥6 to <12 years | Experimental | Drug: Eflapegrastim, Drug: ChemotherapyParticipants 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). |
| Cohort 3: ≥2 to <6 years | Experimental | Drug: Eflapegrastim, Drug: ChemotherapyParticipants 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). |
| Cohort 4: ≥1 month to <2 years | Experimental | Drug: Eflapegrastim, Drug: ChemotherapyParticipants 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). |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
- Participant has had spinal radiation therapy within 30 days prior to study enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EflapegrastimAlso: Rolontis®, SPI-2012Eflapegrastim supplied in prefilled, single-use syringes for SC injection. | Drug | Cohort 1: ≥12 to <17 years, Cohort 2: ≥6 to <12 years, Cohort 3: ≥2 to <6 years, Cohort 4: ≥1 month to <2 years |
| ChemotherapyChemotherapy 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. | Drug | Cohort 1: ≥12 to <17 years, Cohort 2: ≥6 to <12 years, Cohort 3: ≥2 to <6 years, Cohort 4: ≥1 month to <2 years |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 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.
6 secondary outcomes
Percentage of Participants With Severe Neutropenia in Cycle 1
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 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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eflapegrastim and Chemotherapy in people with Solid Tumors and Lymphoma, run by Spectrum Pharmaceuticals, Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Howard Franklin, MD (224.419.7106, Hfranklin@assertiotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug to 35 days after the last dose of the study drug (Up to approximately 16 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.