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CTRI Number  CTRI/2009/091/000073 [Registered on: 01/04/2009]
Last Modified On: 13/03/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the efficacy and safety of low-dose versus standard-dose Filgrastim in chemotherapy induced Neutropenia.  
Scientific Title of Study   A randomized open labeled parallel group phase III study of low-dose versus standard-dose granulocyte colony stimulating factor prophylaxis in pediatric cancer patients receiving myelosuppressive chemotherapy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Brijesh Arora 
Designation   
Affiliation   
Address  Dept. of Medical Oncology
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India 
Phone  022- 24177220  
Fax  022-24146937  
Email  brijesharora@rediffmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr. Brijesh Arora 
Designation   
Affiliation  Assistant Proffessor, Medical Oncology 
Address  Dept. of Medical Oncology
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India 
Phone  022- 24177220  
Fax  022-24146937  
Email  brijesharora@rediffmail.com   
 
Details of Contact Person
Public Query  
Name  Dr. Brijesh Arora 
Designation   
Affiliation   
Address  Dept. of Medical Oncology
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India 
Phone  022- 24177220  
Fax  022-24146937  
Email  brijesharora@rediffmail.com   
 
Source of Monetary or Material Support  
Terry fox foundation. 
 
Primary Sponsor
Modification(s)  
Name  Terry Fox Foundation 
Address  The Terry Fox Foundation Suite 303, 46167 Yale Road Chilliwack, BC V2P 2P2 Tel: (604) 701-0246 Fax: (604) 701-0247 e-mail: national@terryfoxrun.org 
Type of Sponsor  Other [Non-profit International institution for cancer research] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Brijesh Arora  TMH, Mumbai  Dept. of Medical Oncology,Tata Memorial Hospital (TMH)-400012
Mumbai
MAHARASHTRA 		 022- 24177220
022-24146937
brijesharora@rediffmail.com  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hospital Ethics Committee (HEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Chemotherapy induced neutropenia in children. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low-dose Filgrastim    Start on 2.5 mcg/kg/day, starting from 2nd day of the end of chemo cycle (NOT to be given within 24 hrs of chemo), daily till post ANC>5000/cmm on 2 occasions.  EOS at end of one chemotherapy cycle.  CBC and platelet count to be obtained before starting treatment and monitored daily.  If absolute Neutrophil count (ANC) post-nadir > 5 x 109 /L then further study treatment to be discontinued for that particular cycle (due to potential complications of leukocytosis)  
Comparator Agent  Standard ?dose Filgrastim    Start on 5 mcg/kg/day, starting from 2nd day of the chemo cycle (NOT to be given within 24 hrs of chemo), daily till post ANC>5000/cmm on 2 occasions.  EOS at end of one chemotherapy cycle.  CBC and platelet count to be obtained before starting treatment and monitored daily.  If absolute Neutrophil count (ANC) post-nadir > 5 x 109 /L then further study treatment to be discontinued for that particular cycle (due to potential complications of leukocytosis)  
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  &#61600; Newly diagnosed pediatric (age < 18 yrs) patients with acute lymphoblastic leukemia in first complete remission after induction and planned for consolidation chemotherapy or patients with rhabdomyosarcoma (RMS)/Ewing?s sarcoma (ES) and osteogenic sarcoma (OGS) planned for first cycle of chemotherapy. &#61600; ECOG performance status < 2 (Karnofsky >=60%). &#61600; Life expectancy of greater than 6 months. &#61600; Patients must have normal organ and marrow function as defined below - Leukocytes > 3,000/mcL - absolute Neutrophil count > 1,500/mcL - platelets > 100,000/mcL - total bilirubin - within normal institutional limits - AST (SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal. - creatinine - within normal institutional Limits - creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. &#61600; Bone marrow in remission (< 5% blasts in marrow) in ALL or not involved at baseline in RMS and OGS &#61600; Ability of patients to understand and the willingness to sign a written informed consent.  
 
ExclusionCriteria 
Details  &#61600; Patients who have had GCSF prior to entering the study or those who have not recovered from adverse events due to agents administered earlier. &#61600; Patients may not be receiving /received any other investigational agents within past 4 weeks. &#61600; Any planned radiotherapy during the study period. &#61600; History of allergic reactions attributed to compounds of similar chemical or biologic composition to G-CSF. &#61600; Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. &#61600; Prior systemic anti-infective treatment within 72 hours of chemotherapy.  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of grade IV neutropenia between the two arms.  2 years (At the end of study) 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary efficacy endpoints would include comparative incidence of grade IV neutropenia, depth of Neutrophil nadir (mean + sd), total number of antibiotic and hospital days, total number of days of G-CSF total dose of G-CSF and relative safety as measured by reports of adverse events and changes in laboratory values between two arms.   2 years (At the end of study) 
 
Target Sample Size
Modification(s)  		 Total Sample Size="172"
Sample Size from India="172" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  21/03/2008 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a randomized, open labeled, parallel group phase III study to compare the efficacy, safety and cost effectiveness of low-dose non-glycosylated G-CSF (2.5 µg/kg/day) in 172 chemotherapy-induced neutropenia patients visiting Tata Memorial Centre, Mumbai, India. The primary objective being the comparison of efficacy, safety of low-dose versus standard-dose non-glycosylated G-CSF prophylaxis. The secondary objective is to compare the cost-effectiveness of low-dose with standard-dose non-glycosylated G-CSF in CIN. 
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