A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
Condition: Neutropenia
MeSH terms: Neutropenia
Intervention: tbo-filgrastim
Intervention description: 5 μg/kg
Intervention MeSH terms: Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 1 Month
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Neutropenia

Summary:

      The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and
      efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children
      and adolescents with solid tumors without bone marrow involvement.
    

Eligibility criteria:

        Inclusion:

          1. Male or female infants, children and adolescents aged 1 month to <16 years.

          2. Patients with solid tumors without bone marrow involvement, who are scheduled to
             receive myelosuppressive CTX.

          3. Body weight ≥5 kg.

          4. Patients must have an initial diagnosis and histologic proof of their malignancy. All
             enrolled subjects should have signed consent for a CTX regimen that is known to be
             myelotoxic, with counts expected to drop below the absolute neutrophil count (ANC) of
             0.5 × 109/L for at least 3 days. These regimens would include at least one of the
             following:

               -  Etoposide

               -  doxorubicin

               -  ifosfamide

               -  cyclophosphamide

          5. ANC and platelet count: Patients must have an ANC >1 × 109/L and a platelet count >100
             × 109/L to be eligible for therapy at the start of CTX.

          6. Normal cardiac, renal, and hepatic function.

          7. All subjects must have a life expectancy of 12 weeks or more.

          8. Performance Status: Lansky performance score >60 (age 1 to <16 years).

               -  More criteria may apply, please contact the investigator for more information.

        Exclusion:

          1. Bone marrow involvement.

          2. Active myelogenous leukemia or history of myelogenous leukemia.

          3. Previous treatment with colony-stimulating factors (granulocyte colony-stimulating
             factor [G-CSF], granulocyte-macrophage colony-stimulating factor, interleukin 11
             [IL-11]) less than 6 weeks prior to study entry.

          4. History of congenital neutropenia or cyclic neutropenia.

          5. Pregnant or nursing female patients.

          6. Fertile patients who do not agree to use highly reliable contraceptive measures Prior
             bone marrow or stem cell transplant, or prior radiation to ≥25% of bone marrow within
             the 4 weeks prior to the first tbo-filgrastim dose.

          7. Ongoing active infection or history of infectious disease within 2 weeks prior to the
             screening visit.

          8. Treatment with lithium at screening or planned during the study

               -  More criteria may apply, please contact the investigator for more information.