The Study will be conducted in Paediatric Patients Under 6 Years of Age with Rhabdomyosarcoma or Wilms’ Tumour on Myelosuppressive Chemotherapy Regimen by giving Pegfilgrastim PFS Against Neupogen® Injection.
Phase 3
Not yet recruiting
- Conditions
- Malignant neoplasm of connective and soft tissue, unspecified,
- Registration Number
- CTRI/2022/06/043430
- Lead Sponsor
- Intas Pharmaceuticals Limited India
- Brief Summary
A Randomized, Active-Controlled, Multicenter, Open label, Two Arm Study to Assess Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics with Pegfilgrastim PFS of Intas Pharmaceutical Limited Compared with Neupogen® Injection in Paediatric Patients Under 6 years of Age with Rhabdomyosarcoma or Wilms’ Tumour on Myelosuppressive Chemotherapy (CmT) Regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 12
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
- 1.Known hypersensitivity to any component of this product.
- 2.Previous treatment with long acting G-CSF.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 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 Outcome Measures
Name Time Method 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. Total time (days) in hospital across all cycles;
Trial Locations
- Locations (14)
Deenanath Mangeshkar Hospital
🇮🇳Pune, MAHARASHTRA, India
Department of Pediatrics, Sir Ganga Ram Hospital
🇮🇳Delhi, DELHI, India
Dr. BRA IRCH, AIIMS, New Delhi
🇮🇳Central, DELHI, India
HBCH Varanasi
🇮🇳Varanasi, UTTAR PRADESH, India
Kasturba Medical college Hospital
🇮🇳Bangalore, KARNATAKA, India
Kiran Hospital Multisuper speciality hospital & research Centre
🇮🇳Surat, GUJARAT, India
Mahatma Gandhi Cancer Hospital & research Institute, Andra Pradesh, India
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Max Super speciality Hospital, Saket
🇮🇳Delhi, DELHI, India
MNJ Institute of Oncology & Regional Cancer Center
🇮🇳Hyderabad, TELANGANA, India
NRS Medical College and Hospital Dept. of Pediatric Surgery
🇮🇳Kolkata, WEST BENGAL, India
Scroll for more (4 remaining)Deenanath Mangeshkar Hospital🇮🇳Pune, MAHARASHTRA, IndiaDr Shailesh KanvindePrincipal investigator8087004425skanvin@gmail.com