Study on the Safety and Effects of Eflapegrastim in Children with Solid Tumors or Lymphomas Undergoing Chemotherapy

Sponsor: Spectrum Pharmaceuticals, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04570423

Provider View

This clinical trial is testing the safety and how the body processes a drug called eflapegrastim in children with solid tumors or lymphomas who are receiving chemotherapy that affects bone marrow.

Patient Parameters

Program Overview

The study aims to find out if eflapegrastim is safe and how it behaves in the body of children with solid tumors or lymphomas who are receiving chemotherapy that lowers blood cell counts. The trial will include about 40 children, divided into four age groups. All participants will receive their usual chemotherapy treatment, followed by an injection of eflapegrastim for up to four treatment cycles.

Description

This is a Phase 2 study, meaning it is focused on evaluating the safety and effects of eflapegrastim in children aged 1 month to under 17 years who have solid tumors or lymphomas. The study will take place at multiple centers and will include about 40 children. They will be divided into four groups based on age. The first group will be monitored for any serious side effects before the other groups begin treatment.

All children in the study will receive their standard chemotherapy treatment. Afterward, they will receive an injection of eflapegrastim under the skin for up to four treatment cycles. The study will help determine if eflapegrastim is safe for children and how it is processed in their bodies.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of a solid tumor or lymphoma that has not spread to the bone marrow.
  • Must be eligible to receive chemotherapy that lowers blood cell counts, with a risk of fever and low white blood cells of at least 20%.
  • Must have good blood, kidney, and liver function.
  • Must have a heart test showing a pumping ability greater than 50% if receiving heart-affecting treatment.
  • Must have a spinal tap if needed to check for cancer spread to the brain or spinal cord.
  • Must have a performance level of at least 50% on a specific scale for their age group, indicating they can perform daily activities.

Exclusion Criteria

  • Cannot have an uncontrollable infection or other serious illness that would prevent receiving the study treatment.
  • Cannot have used similar drugs like filgrastim or pegfilgrastim recently.
  • Cannot need radiation therapy during the first treatment cycle.
  • Cannot have had a bone marrow or stem cell transplant or have cancer involving the bone marrow.
  • Cannot have had spinal radiation therapy recently.
  • Cannot have used experimental drugs or devices recently or plan to use them during the study.
  • Cannot have allergies to similar drugs.
  • Cannot have active cancer in the brain or spinal cord.
  • Must have recovered from any previous treatment side effects to a mild level.

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