CTRI/2022/06/043430 [Registered on: 22/06/2022] Trial Registered Prospectively
Last Modified On:
07/10/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Other
Public Title of Study
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.
Scientific Title of Study
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
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
0298-21, Version 2.0 dated 25 August 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Prashant Modi
Designation
Sr. General Manager
Affiliation
Lambda Therapeutic Research Ltd.
Address
Lambda house, Plot No. 38, Survey no. 388, Near Silver Oak Club,S.G. Highway, Gota,
Ahmadabad GUJARAT 382481 India
Phone
07940202375
Fax
07940202021
Email
prashantmodi@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Naman Shah
Designation
Sr. General Manager
Affiliation
Lambda Therapeutic Research Ltd.
Address
Lambda house, Plot No. 38, Survey no. 388, Near Silver Oak Club, S.G. Highway, Gota,
Ahmadabad GUJARAT 382481 India
Phone
07940202389
Fax
07940202021
Email
namanshah@lambda-cro.com
Details of Contact Person Public Query
Name
Prashant Modi
Designation
Sr. General Manager
Affiliation
Lambda Therapeutic Research Ltd.
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club, S. G. Highway, Gota,
Ahmadabad GUJARAT 382481 India
Phone
07940202214
Fax
07940202021
Email
prashantmodi@lambda-cro.com
Source of Monetary or Material Support
Intas Pharmaceuticals Limited India,Corporate House, Nr. Sola Bridge, S. G. Highway,Thaltej,
Ahmedabad – 380054. Gujarat, India
Primary Sponsor
Name
Intas Pharmaceuticals Limited India
Address
Corporate House,Nr. Sola Bridge, S. G. Highway,
Thaltej,Ahmedabad – 380 054. Gujarat, India
Department of Clinical Research, Room No. NA, Deenanath Mangeshkar Hospital and Research centre, Erandwane, Pune-411004. Pune MAHARASHTRA
8087004425
skanvin@gmail.com
Dr Anupam Sachdeva
Department of Pediatrics, Sir Ganga Ram Hospital
Department of Clinical Research, Room No. NA, Sir Ganga Ram Hospital, Sir Ganga Ram Hospital marg, Rajinder nagar, New Delhi, Delhi 110060, India. New Delhi DELHI
9811043476
anupamace@yahoo.co.in
Prof Sameer Bakhshi
Dr. BRA IRCH, AIIMS, New Delhi
Department of medical oncology, DR BRA IRCH, NEW DELHI Central DELHI
9958828763
sambakh@hotmail.com
Dr Vikramjit S Kanwar
HBCH Varanasi
Homi Bhabha cancer Hospital, Ghanti Mill road, Lahartara, Varanasi UP 2201005 Varanasi UTTAR PRADESH
7355635969
vikramjit.kanwar@gmail.com
Dr Harsha Prasad L
Kasturba Medical college Hospital
Kasturba medical college Hospital,
NG Road, Attavar, Mangalore-575001, Karnataka, India Bangalore KARNATAKA
9480157864
drlhprasad@yahoo.com
Dr Anshul Agrawal
Kiran Hospital Multisuper speciality hospital & research Centre
Department of Clinical
Research,Room No. NA, Kiran Hospital Multisuper speciality hospital & research Centre, Near Sumul Dairy, Surat-395004,India Surat GUJARAT
9824196710
anshul.onco@gmail.com
DrRajani Priya Yedla
Mahatma Gandhi Cancer Hospital & research Institute, Andra Pradesh, India
Department of Clinical Research, Room No. NA, 1/7 MVP colony,Visakhapatnam-530017, Andra Pradesh, India. Visakhapatnam ANDHRA PRADESH
9824389004
drrajnipriya@gmail.com
Dr Ramandeep Singh Arora
Max Super speciality Hospital, Saket
Max Super speciality Hospital, saket(east block) A unit of Devki Devi Foundation,2 press enclave road, Saket, New Delhi-110017 New Delhi DELHI
8375017305
childhoodcancer@gmail.com
Dr PK Chaithanya
MNJ Institute of Oncology & Regional Cancer Center
MNJ Institute of Oncology & Regional Cancer Center, Red Hills, Hyderabad Telengana 500004 Hyderabad TELANGANA
8897199994
mnjiorccchaithanya@gmail.com
Dr Koushik Saha
NRS Medical College and Hospital Dept. of Pediatric Surgery
Department of clinical research,Room No.N/A,Dept of padeatric surgery
NRS Medical College & Hospital 138 A.J.C. Bose road Kolkata 700014 Kolkata WEST BENGAL
9831304491
drsahakaushik@yahoo.com
Dr Ramavath Devendra Naik
Omega Hospital
Omega Hospital,Plot No 04
Healthcity Chinagadili,
Hanumanthavaka Vishakhapatnam Andra Pradesh 530040 Visakhapatnam ANDHRA PRADESH
9873742322
drramavathdev@gmail.com
Dr Nita Radhakrishnan
Post Graduate Institute of Child health
Department of Clinical Research,Room No. NA,Post Graduate Institute of Child Health Sector -30 Noida Gautam Budh Nagar Noida Uttar Pradesh 201303 Gautam Buddha Nagar UTTAR PRADESH
9999041524
nitark@gmail.com
Dr Faisal RGuru
SKIMS
Sher-i-Kashmir institute of medical sciences,South, srinagar,J&K 190011 Srinagar JAMMU & KASHMIR
9717017022
faisal_guru@yahoo.com
Dr Nitin Joshi
The Gujrat Cancer & research institute
Department of Clinical Research, Room No. NA, The Gujrat Cancer & research institute New Civil Hospital Campus Asarwa Ahmedabad Ahmadabad GUJARAT
IEC, Nil Ratan Sircar Medical College and Hospital, Dr Koushik Saha
Approved
IEC,Post Graduate Institute of Child Health,Dr. Nita Radhakrishnan
Approved
Institutional Ethics committee, Dr. Faisal .R. Guru
Approved
Institutional Ethics Committee, Dr. Ramandeep Singh Arora
Approved
Institutional Ethics committee, Dr. Ramavath Devendra Naik
Submittted/Under Review
Institutional Ethics Committee, Dr. Shailesh Kanvinde
Submittted/Under Review
Institutional Ethics Committee, Dr. Vikramjit S. Kanwar
Approved
Institutional Review board, Mahatma Gandhi Cancer Hospital & research institute, Dr. Rajni Priya Yedla
Approved
Kiran Hospital Ethics Committee, Dr. Anshul Agrawal
Approved
MAHE Ethics Committee, Dr. Harsha Prasad L
Approved
MNJ Institute of Oncology& Regional Cancer Center Ethics Committee, Dr. P.K. Chaithanya
Approved
Sir Ganga Ram Hospital Ethics committee, Dr. Anupam Sachdeva
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C499||Malignant neoplasm of connective and soft tissue, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Neupogen Singleject (Filgrastim)
Dose formulation:Solution for injection in a pre-filled syringe Adminitration:Subcutaneous Level(s):5 microgram/kg once per day via SC injection
Intervention
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 dose of pegfilgrastim between 24-27 hours after completion each chemotherapy cycle. Dose should be calculated based on the weight of the child before administration of the study intervention.
Inclusion Criteria
Age From
0.00 Year(s)
Age To
6.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
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
Outcome
TimePoints
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;
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.
Target Sample Size
Total Sample Size="12" Sample Size from India="12" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
30/06/2022
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Nil.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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.