A Study to Evaluate the Safety and Pharmacokinetics of Ef... | NCT04570423

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).	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).	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).	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).	Drug: Eflapegrastim

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eflapegrastim	Drug	Eflapegrastim supplied in prefilled, single-use syringes for SC injection.	Cohort 1: ≥12 to <17 years Cohort 2: ≥6 to <12 years Cohort 3: ≥2 to <6 years

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From first dose of study drug to 35 days after the last dose of the study drug (Up to approximately 16 months)

Secondary Outcomes

Measure	Description	Time Frame
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).	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

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 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.
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.

Facility	Status	City	State	ZIP	Country	Contacts
New York Medical College	Terminated	Valhalla	New York	10595	United States
Carolinas Medical Center/ Levine Children's Hospital

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
C583329	eflapegrastim
D004358	Drug Therapy