Health Condition 1: C499- Malignant neoplasm of connective and soft tissue, unspecified
Conditions
Interventions
Intervention1: Pegfilgrastim: Dose formulation:Pre-filled syringe for Injection
Adminitration:Subcutaneous
Level(s):1.5 mg per 0.15 mL, 2.5 mg per 0.25 mL and 4.0 mg per 0.4 mL
Duration: Single SC dos
Sponsors
Intas Pharmaceuticals Limited India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female infants and children from under 6 years of age. 2.Children with a pathologically confirmed diagnosis of rhabdomyosarcoma or high-risk Wilms’tumour, planned for treatment with 1 of the following CmT regimens: 3.Rhabdomyosarcoma: Ifosfamide plus vincristine plus actinomycin D (IVA),Ifosfamide plus vincristine plus actinomycin D plus doxorubicin (IVADo),Vincristine plus actinomycin D plus cyclophosphamide (VAC); High-risk Wilms’ tumour: Cyclophosphamide with doxorubicin and/or etoposide with carboplatin. 4.Written informed consent provided by parent(s)/legal representative(s) of the Paediatric participant and participant’s assent if able to understand and/or follow study instructions alone or with parental assistance. 5.Parents/legally acceptable representative should have signed consent for a CmT regimen that is known to be myelotoxic, with counts expected to drop below an absolute neutrophil count (ANC) of 0.5×10 to the power 9/L for at least 3 days. 6.ANC and platelet count: Participants must have an ANC greater than 1×10 to the power 9/L and a platelet count greater than 100×10 to the power 9/L to be eligible for therapy at the start of CmT. 7.Normal cardiac, renal, and hepatic function. 8.All participants must have a life expectancy of greater than 4 months in the opinion of the investigator. 9.On-treatment Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. 10.Participants with baseline laboratory values acceptable for them to receive chemotherapy.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to any component of this product. 2.Previous treatment with long acting G-CSF. 3.History of congenital neutropenia or cyclic neutropenia. 4.Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint; Bone marrow involvement. 5.Prior bone marrow or stem cell transplant, or prior radiation to greater than or equal to 25% of bone marrow (e.g., whole pelvic radiation) for any reason, or any therapeutic radiation within the 4 weeks prior to the first dose. 6.Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit. 7.A positive polymerase chain reaction test for COVID-19; Treatment with lithium at screening or planned during the study. 8.Participation in an interventional clinical study within 30 days or 5 half-lives of the investigational product before enrollment, whichever is longer. 9.Participants with autoimmune diseases; Participants with severe liver, kidney, heart, or lung dysfunction precluding the expected delivery of the intended chemotherapy regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the efficacy of a subcutaneous (SC) dose administration of pegfilgrastim per chemotherapy cycle compared to daily SC dose administrations of filgrastim in children receiving CmT. Timepoint: Incidence and duration of severe neutropenia (ANC less than 0.5×10 to the power 9/L) in each chemotherapy cycle; Incidence and duration of very severe neutropenia (ANC less than 0.1×10 to the power 9/L) in each chemotherapy cycle; Incidence of febrile neutropenia (body temperature greater than 38.3°C or 2 consecutive readings higher than 37.8°C measured at the axilla or external ear at least 2 hours apart. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the pharmacodynamics, pharmacokinetics, safety, and tolerability including local (injection site) tolerability of a single SC dose administration of pegfilgrastim per chemotherapy cycle compared to daily SC dose administrations of filgrastim in children receiving CmT.Timepoint: Total time (days) in hospital across all cycles; Total time (days) in Intensive Care Unit (ICU) across all cycles; Percentage of scheduled chemotherapy dose that was delivered across all cycles; Proportion with chemotherapy doses reduced, omitted, or delayed across all cycles; Time in days in hospital and time in the ICU due to FN or associated infections across all cycles; Number of days of delay of chemotherapy across all cycles. | — |
Countries
India
Contacts
Public ContactPrashant Modi
Lambda Therapeutic Research Ltd.
Outcome results
None listed