A study of Pegfilgrastim PFS in Paediatric Patients Under 6 years of Age with Rhabdomyosarcoma or Wilms’ Tumour on Myelosuppressive Chemotherapy (CmT) Regimen.

Phase 1

• Conditions: Paediatric Patients Under 6 years of Age with Rhabdomyosarcoma or Wilms’ Tumour on Myelosuppressive Chemotherapy (CmT) Regimen; MedDRA version: 20.0Level: HLGTClassification code 10047954Term: White blood cell disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-004792-14-Outside-EU/EEA
• Lead Sponsor: Intas Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-08
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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:
• 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
3. 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
4. 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 × 109/L for at least 3 days.
5. ANC and platelet count: Participants must have an ANC >1 × 109/L and a pl
atelet count >100 × 109/L to be eligible for therapy at the start of CmT
6.Normal cardiac, renal, and hepatic function
7.All participants must have a life expectancy of >4 months in the opinion of the investigator
8.On-treatment Eastern Cooperative Oncology Group (ECOG) performance status =2
9.Participants with baseline laboratory values acceptable for them to receive chemotherapy
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Any potential participant who meets any of the following criteria will be excluded from participating in the study:
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
5.Bone marrow involvement
6.Prior bone marrow or stem cell transplant, or prior radiation 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
7.Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit
8.A positive polymerase chain reaction test for COVID-19.
9.Treatment with lithium at screening or planned during the study
10.Participation in an interventional clinical study within 30 days or 5 half-lives of the investigational product before enrollment, whichever is longer
11.Participants with autoimmune diseases
12.Participants with severe liver, kidney, heart, or lung dysfunction precluding the expected delivery of the intended chemotherapy regimen

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified