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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.

Must not have

Participant with active CNS disease.

Participant has not recovered from previous treatment adverse events to ≤Grade 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study drug to 35 days after the last dose of the study drug (up to approximately 16 months)

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I will have a lumbar puncture to check for brain or spinal cord involvement if needed.

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I have a confirmed diagnosis of a new or returning solid tumor or lymphoma without bone marrow involvement.

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I am eligible for strong chemotherapy that has a high risk of fever and low white blood cell count.

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I can do most activities by myself, regardless of my age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active brain or spinal cord disease.

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I still experience significant side effects from my previous treatment.

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I need radiation therapy during the first treatment cycle.

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I have had a bone marrow or stem cell transplant, or my cancer affects my bone marrow.

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I have not used any experimental drugs or devices in the last 30 days and do not plan to use any during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug to 35 days after the last dose of the study drug (up to approximately 16 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug to 35 days after the last dose of the study drug (up to approximately 16 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug to 35 days after the last dose of the study drug (up to approximately 16 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Secondary study objectives

Number of Participants With Febrile Neutropenia in Cycle 1

Percentage of Participants With Severe Neutropenia in Cycle 1

Time to Absolute Neutrophil Count (ANC) Recovery of Severe Neutropenia in Cycle 1

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Group III: Cohort 2: ≥6 to <12 yearsExperimental Treatment2 Interventions

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

Eflapegrastim

2020

Completed Phase 1

~60

Chemotherapy

2003

Completed Phase 4

~3050