RecruitingPhase 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 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


Sponsor

Spectrum Pharmaceuticals, Inc

Enrollment

40 participants

Start Date

May 20, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 MonthMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a medication called eflapegrastim, which helps the body produce more white blood cells after chemotherapy, in children with solid tumors or lymphomas. This type of drug (called a G-CSF) can reduce the risk of serious infections during cancer treatment. **You may be eligible if...** - Your child has a confirmed solid tumor or lymphoma (not involving the bone marrow) - Your child is scheduled to receive chemotherapy that carries a high risk of causing low white blood cell counts (febrile neutropenia rate of at least 20%) - Your child's blood counts, kidney, and liver function are adequate - Your child is able to perform basic daily activities (performance score ≥50%) **You may NOT be eligible if...** - Your child has an uncontrolled infection or serious medical condition - Your child has recently received other white blood cell stimulating drugs (filgrastim within 7 days, pegfilgrastim within 14 days) - Your child needs radiation therapy at the same time as chemotherapy in the first cycle - Your child has had a bone marrow transplant or has leukemia - Your child has had spinal radiation within the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEflapegrastim

Eflapegrastim supplied in prefilled, single-use syringes for SC injection.

DRUGChemotherapy

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.


Locations(5)

New York Medical College

Valhalla, New York, United States

Carolinas Medical Center/ Levine Children's Hospital

Charlotte, North Carolina, United States

Levine Children's Health

Charlotte, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

UT MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04570423


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