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RECRUITING
NCT04570423
PHASE2

A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy

Sponsor: Spectrum Pharmaceuticals, Inc

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

1 Month - 17 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2021-05-20

Completion Date

2027-10

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

DRUG

Eflapegrastim

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

DRUG

Chemotherapy

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