Phase
Condition
Solid Tumors
Lymphoma
Treatment
Eflapegrastim
Chemotherapy
Clinical Study ID
Ages 1-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must have a pathologic/histologic confirmed newlydiagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrowinvolvement.
Participant must be a candidate to receive myelosuppressive chemotherapy, with afebrile neutropenia rate of at least 20% as outlined in the National ComprehensiveCancer 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 cardiacejection fraction of >50%.
Participant must have a lumbar puncture, if clinically indicated, to rule outcentral nervous system (CNS) involvement within 14 days of study entry.
Participant has a Karnofsky performance level ≥50% for patients ≥16 years of age ora Lansky performance level ≥50 for children <16 years of age.
Exclusion
Exclusion Criteria:
Participant has an uncontrollable infection, has an underlying medical condition,and/or another serious illness that would impair the ability of the participant toreceive 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 inclinical 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/orhas concurrent bone marrow involvement in their malignancy, including leukemia.
Participant has had spinal radiation therapy within 30 days prior to studyenrollment.
Participant has used any investigational drugs, biologics or devices within 30 daysprior to study treatment or plans to use any of these during the study.
Participant has a known sensitivity or previous reactions to any of the G-CSFproducts.
Participant with active CNS disease.
Participant has not recovered from previous treatment adverse events to ≤Grade 1.
Study Design
Study Description
Connect with a study center
New York Medical College
Valhalla, New York 10595
United StatesActive - Recruiting
Carolinas Medical Center/ Levine Children's Hospital
Charlotte, North Carolina 28203
United StatesActive - Recruiting
Levine Children's Health
Charlotte, North Carolina 28203
United StatesActive - Recruiting
UT MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.