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1 Clinical Trial Details (PDF Generation Date :- Wed, 19 Dec :45:15 GMT) CTRI Number Last Modified On 25/12/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/11/ [Registered on: 14/11/2014] - Trial Registered Retrospectively No Interventional Drug Randomized, Parallel Group Trial TRIAL COMPARING EFFECTIVENESS OF TWO STANDARD CHEMOTHERAPY REGIMENS IN TREATMENT OF CHILDHOOD ACUTE MYELOID LEUKEMIA Randomized Phase III Study Comparing DA (3 plus 7) Versus ADE as Induction Chemotherapy in children with Acute Myeloid Leukemia Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator No:38, Sardar Patel Road, Guindy, Adyar No:38, Sardar Patel Road, Guindy, Adyar Details Contact Person (Scientific Query) No:38, Sardar Patel Road, Guindy, Adyar No:38, Sardar Patel Road, Guindy, Adyar Details Contact Person (Public Query) No:38, Sardar Patel Road, Guindy, Adyar No:38, Sardar Patel Road, Guindy, Adyar page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent > Cancer Institute, Source of Monetary or Material Support Primary Sponsor Details Cancer Institute WIA No:38, Sardar Patel Road, Guindy, Adyar Type of Sponsor List of Countries of Principal Investigator Dr Sameer Bakhshi VENKATRAMAN R Dr Sudha Sinha Research institution and hospital of Site Site Phone// All Institute of Medical Sciences CANCER INSTITUTE (W.I.A) MNJ institute of oncology and regional cancer centre Department of Medical Oncology IRCH, AIIMS Ansari Nagar New Delhi sambakh@hotmail.com South DELHI Cancer Institute, Department of Medical Oncology, 38 SARDAR PATEL ROAD GUINDY CHENNAI Red Hills, Hyderabad, Hyderabad ANDHRA PRADESH sudhamd@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institute ethics committee AIIMS Approved 04/10/2016 No Institute ethics Approved 29/08/2016 No committee MNJ hospital Institutional Ethics Committee, Cancer Institute (WIA) Approved 10/06/2017 No JIPMER Approved 16/11/2017 No Status Not Applicable Health Type Patients Date No Date Specified Condition Type Details Intervention ADE chemotherapy Ara-c (A) 200 mg/sqm day 1 to day 10 twice daily as intravenous bolus They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification excluding APML daunorubicin,etoposide,ara c is a standard of care for treating pediatric AML page 2 / 5

3 Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Comparator Agent Age From Age To Gender Details Details for first induction and 200 mg/sqm/day, day 1 to day 8 twice daily as intravenous bolus for second induction. Daunorubicin (D) 50 mg/sq m day 1,3 and 5, as intravenous infusion in 500 ml normal saline over 2 hours Etoposide (E) 100 mg/sq m, day 1 to 5, intravenous infusion in 500 ml normal saline over 2 hours DA chemotherapy Daunorubicin (D) 60 mg /sq m/day, day 1 to day 3 as intravenous infusion in 500 ml normal saline over 2 hours ARA-C (A) 100 mg/sq m/day continuous infusion day 1 to day Year(s) Year(s) Both Computer generated randomization An Open list of random numbers Open Label Inclusion Criteria ARA-C, DAUNORUBICIN (DA) IS A STANDARD OF CARE IN PEDIATRIC AML. The trial will compare the efficacy and safety of the two standard of care regimen in pediatric AML. 1.They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification (Appendix A) excluding APML. 2. They are considered suitable for intensive chemotherapy. 3. They should be under the age of They have given written informed consent 5. HepB,HIV,HCV negative. Exclusion Criteria 1. Age more than 18 years 2. Children with APML 3. Abnormal Renal function test 4. Abnormal liver functions 5. ECOG Performance status >2 6. Pregnancy in case of females 7. Cardiac dysfunction 8. HBsaG/HIV/HCV Seropositive cases 9. Patients not giving consent. 10. They have previously received cytotoxic chemotherapy for AML. 11. They have a concurrent active malignancy 12. The physician and patient consider that intensive therapy is not an appropriate treatment option Primary Outcome Outcome Timepoints Compare the CR rates between both the regimens in patients with AML aged less than 18 years old Complete remission (CR) achievement at end of induction chemotherapy. Toxicity, both haematological and non-haematological at the end of each cycle of chemotherapy. Overall survival in both arms at the end of last follow-up Secondary Outcome Outcome Timepoints Compare overall survival, event free survival and Death and relapse page 3 / 5

4 Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary toxicity between DA and ADE chemotherapy Total Sample Size=186 Sample Size from =186 01/06/2014 No Date Specified Years=5 Months=0 Days=0 Not Applicable Open to Recruitment INTRODUCTION Pediatric Acute myeloid leukaemia (AML) may have a different biology compared to adult AML. Acute myeloid leukaemia (AML) is composed of a heterogeneous group of disease that can be classified by morphology, lineage and genetics. This heterogeneity reflects the diversity of myeloid precursors that are susceptible to malignant transformation and the variety of genetic events that can lead to this transformation. There is no data to show whether a standard 3+7 approach used in the adult patients would be adequate for therapy of AML. All major trials globally have shown a CR rate of 70-80% and an overall survival of around 60%. Most of these trials have used different regimens which included daunorubicin, cytosine arabinoside, etoposide, 6TG and mitoxantrone. There is little data from for paediatric AML. We analyzed our data on paediatric AML treated page 4 / 5

5 Powered by TCPDF ( PDF of Trial between From , DA (39) and between (26) ADE was used as the induction regimen. There were no major differences between the two regimens (DA and ADE) in terms of CR, OS and toxicities. Even though a high CR rate was achieved with both regimens, overall survival continued to remain poor due to relapse of leukemic among the intermediate and high risk patients. The actuarial survival of all patients was 40%. STUDY RATIONLE: It is unclear given the above data the correct approach to initial treatment of AML in children in our setting. The question still remains whether addition of etoposide will improve overall survival. Evaluation of cytogenetics, immunophenotype and minimal residual disease (MRD) which will be performed in this trial will add to information and risk stratification. This study intends to compare two indication regimens (DA vs. ADE) in Pediatric AML. All patients will receive 2 cycles of consolidation with high dose cytosine arabinoside. Eligible high and intermediate risk patients will be offered allogenic bone marrow transplantation. The primary end points are CR and toxicities, secondary endpoints is overall survival. page 5 / 5