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Eflapegrastim for Pediatric Cancer

Phase 2
Recruiting
Research Sponsored by Spectrum Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (CNS) involvement within 14 days of study entry.
Participant must have a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights

Study Summary

This trial will test the safety and how eflapegrastim affects the body in children with cancer who are undergoing chemotherapy.

Who is the study for?
This trial is for children with solid tumors or lymphoma who are getting strong chemotherapy. They must have a high risk of fever and low white blood cell counts, no bone marrow cancer, good heart function, and be able to do some daily activities. Kids can't join if they've had certain treatments recently, have an infection that's not under control, or are sensitive to drugs similar to Eflapegrastim.Check my eligibility
What is being tested?
The study tests the safety and how the body processes Eflapegrastim in kids receiving chemotherapy that lowers their white blood cells. It aims to see if this drug can help prevent infections by increasing white blood cells after chemo.See study design
What are the potential side effects?
Possible side effects of Eflapegrastim may include reactions at the injection site, bone pain, muscle aches, headache and tiredness. Since it boosts white blood cells quickly after chemo, there might also be side effects related to immune system activation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I will have a lumbar puncture to check for brain or spinal cord involvement if needed.
Select...
I have a confirmed diagnosis of a new or returning solid tumor or lymphoma without bone marrow involvement.
Select...
I am eligible for strong chemotherapy that has a high risk of fever and low white blood cell count.
Select...
I can do most activities by myself, regardless of my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Secondary outcome measures
Elimination Half-life (t½) of Eflapegrastim in Cycle 1
Number of Participants With Febrile Neutropenia in Cycle 1
Peak Concentration (Cmax) of Eflapegrastim in Cycle 1
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: ≥1 month to <2 yearsExperimental Treatment2 Interventions
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).
Group II: Cohort 3: ≥2 to <6 yearsExperimental Treatment2 Interventions
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).
Group III: Cohort 2: ≥6 to <12 yearsExperimental Treatment2 Interventions
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).
Group IV: Cohort 1: ≥12 to <17 yearsExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050

Find a Location

Who is running the clinical trial?

Spectrum Pharmaceuticals, IncLead Sponsor
82 Previous Clinical Trials
8,149 Total Patients Enrolled
25 Trials studying Lymphoma
2,497 Patients Enrolled for Lymphoma

Media Library

Eflapegrastim Clinical Trial Eligibility Overview. Trial Name: NCT04570423 — Phase 2
Lymphoma Research Study Groups: Cohort 2: ≥6 to <12 years, Cohort 3: ≥2 to <6 years, Cohort 1: ≥12 to <17 years, Cohort 4: ≥1 month to <2 years
Lymphoma Clinical Trial 2023: Eflapegrastim Highlights & Side Effects. Trial Name: NCT04570423 — Phase 2
Eflapegrastim 2023 Treatment Timeline for Medical Study. Trial Name: NCT04570423 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have been chosen to participate in this clinical trial?

"To move forward with this research, 40 patients who meet the specific inclusion criteria are required to participate. These individuals can choose to enroll at different locations, such as New york Medical College or UT MD Anderson Cancer Center."

Answered by AI

How can I join forces with other patients in this experiment?

"This study is seeking to enroll 40 lymphoma patients that are 1 month to 17 years old. Eligibility requirements include: a recently diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement that has been pathologically confirmed, candidacy for myelosuppressive chemotherapy with a febrile neutropenia rate in accordance with National Comprehensive Cancer Network (NCCN) guidelines, adequate hematological, renal, and hepatic function, an echocardiogram (ECHO) or multigated acquisition (MUGA) within 14 days of screening if the patient will be receiving cardiotoxic"

Answered by AI

Are there other Eflapegrastim trials similar to this one that have already been completed?

"Eflapegrastim was first researched in 2020 by SCL Health Research Institute, Inc. and there have been 77 completed clinical trials since then. Out of the 2 ongoing studies, a significant proportion are taking place in Valhalla, New york."

Answered by AI

Does this research have any predecessors?

"2 different ongoing clinical trials are studying Eflapegrastim in 11 cities and 1 nation. The first research project occurred in 2020. That year, the Phase 1 drug approval process was completed for this medication after 90 patients were studied by Spectrum Pharmaceuticals, Inc. Since then, 77 more investigations have been launched."

Answered by AI

Does this research project have an age limit?

"This particular clinical trial is designed for children aged 1 month to 17 years old. Out of the 2358 total trials, 341 are for people under 18 and 2017 are for senior citizens."

Answered by AI

What are some of the risks associated with Eflapegrastim?

"Eflapegrastim's safety is based on preliminary data from Phase 2 trials. While there is evidence that it is safe, efficacy has not been conclusively shown."

Answered by AI

Is this research still looking for participants?

"This trial, which was created on 5/20/2021 and updated most recently on 2/28/2022, is recruiting patients according to the clinicaltrials.gov website."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
2021. "A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04570423.
~22 spots leftby Oct 2027
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