CTRI Number	CTRI/2015/12/006434 [Registered on: 11/12/2015] Trial Registered Prospectively
Last Modified On:	09/11/2019
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Other (Specify) [Standardisation of treatment]
Study Design	Randomized, Parallel Group, Active Controlled Trial
Public Title of Study Modification(s)	A collaborative, multicentre, national study for newly diagnosed patients with acute lymphoblastic leukaemia
Scientific Title of Study	Randomised open label phase IV study for patients with newly diagnosed Acute Lymphoblastic Leukaemia (Indian Childhood Collaborative Leukaemia Group Study ALL 2014)
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Prof Vaskar Saha  Address  Tata Medical Center, Kolkata. 14 (E-W) Major Arterial Road New Town, Rajarhat. Kolkata Kolkata WEST BENGAL 700160 India  Phone  03366057089   Fax  03366057578   Email  vaskar.saha@tmckolkata.com
Details Contact Person Scientific Query	Name  Prof Vaskar Saha  Address  Tata Medical Center, Kolkata. 14 (E-W) Major Arterial Road New Town, Rajarhat. Kolkata Kolkata WEST BENGAL 700156 India  Phone  03366057089   Fax  03366057578   Email  vaskar.saha@tmckolkata.com
Details Contact Person Public Query Modification(s)	Name  Dr Nandana Das  Address  Tata Medical Center, Kolkata. 14 (E-W) Major Arterial Road New Town, Rajarhat. Kolkata Kolkata WEST BENGAL 700160 India  Phone  03366057089   Fax  03366057578   Email  nandana.das@tmckolkata.com
Source of Monetary or Material Support Modification(s)	Wellcome DBT India Alliance Margdarshi Fellowship. Part support for staffing; National Cancer Grid and Indian Council of Medical Research for Trial Support.
Primary Sponsor	Name  Tata Medical Center Kolkata  Address  14 (E-W) Major Arterial Road New Town, Rajarhat. Kolkata-700-156   Type of Sponsor  Research institution and hospital
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 7   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Prof Rachna Seth  All India Institute of Medical Sciences  Division of Paediatric Oncology, Department of Paediatrics, Ansari Nagar, New Delhi 110029, India New Delhi   01126594345 01126594164 drrachnaseth@yahoo.co.in  Dr Venkatraman Radhakrishnan  Cancer Institute (WI-A)  18, East Canal Bank Road, Gandhi Nagar, Adyar, Chennai, Tamil Nadu 600020 Chennai   04424911526 04424912085 venkymd@gmail.com  Dr Sameer Bakhshi  Dr.B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences  IRCH, Ansari Nagar East, New Delhi 110 029 New Delhi   01126585237 01126588663 sambakh@hotmail.com  Dr Ramandeep Singh Arora  Max Super Speciality Hospital  2, Press Enclave Road, Saket New Delhi-110017, India New Delhi   01126515050 01126510050 childhoodcancer@gmail.com  Dr Amita Trehan  Postgraduate Institute of Medical Education & Research  Kairon Block, Sector 12, Chandigarh, 160012 Chandigarh   01722746018 01727444001 trehanamita@hotmail.com  Dr Shekhar Krishnan  Tata Medical Center Kolkata  14 (E-W) Major Arterial Road. New Town. Rajarhat. Kolkata-700156 Kolkata   03366057089 03366057578 shekhar.krishnan@tmckolkata.com  Dr Gaurav Narula  Tata Memorial Hospital Mumbai  Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012 Mumbai   02224177000 02224146937 drgauravnarula@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 6   Name of Committee  Approval Status  Cancer Institute Ethics Committee Adyar (WIA) (Chennai)  Approved  Instituitional Ethics Committee, MAX Super Speciality Hospital (New Delhi)  Approved  Institute Ethics Committee, All India Institute Of Medical Sciences (New Delhi)  Approved  Institute Ethics Committee, Post Graduate of medical Education and Research (Chandigarh)  Approved  Tata Medical Center-Instituitional Review Board (Kolkata)  Approved  Tata Memorial Centre, Instituitional Ethics Committee (Mumbai)  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Acute lymphoblastic leukemia [ALL]  Patients  Acute lymphoblastic leukemia [ALL]  Patients  Childhood Acute Lymphoblastic Leukaemia
Intervention / Comparator Agent	Type  Name  Details  Intervention  Randomisation 1   3 weeks of pulsed prednisolone during Induction for Standard Risk and Intermediate Risk B-Cell Precursor ALL  Comparator Agent  Randomisation 1  5 weeks of continuous prednisolone during Induction for Standard Risk and Intermediate Risk B-Cell Precursor ALL  Intervention  Randomisation 2  One dose of Mitoxantrone during Delayed Intensification in all patients with newly diagnosed ALL  Comparator Agent  Randomisation 2  Three doses of Doxorubicin during Delayed Intensification in all patients with newly diagnosed ALL
Inclusion Criteria	Age From  1.00 Year(s) Age To  18.00 Year(s) Gender  Both  Details  Previously untreated newly-diagnosed ALL including T lymphoblastic lymphoma
ExclusionCriteria	Details  Previously treated patients, patients with Down syndrome and patients with mature B-ALL
Method of Generating Random Sequence	Stratified block randomization
Method of Concealment	Centralized
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  1.Event-free and Overall survival in all patients and within risk groups 2.Treatment toxicity in patients treated with 3 weeks of pulsed corticosteroid vs 5 weeks of continuous steroid during Induction in patients with Standard and Intermediate Risk B-Cell Precursor ALL (First randomisation) 3.Event-free and overall survival in patients treated with 1 dose of Mitoxantrone vs 3 doses of Doxorubicin during Delayed Intensification in all patients(Second Randomisation)  At end of study and at 3 years from close of study
Secondary Outcome	Outcome  TimePoints  1. Comparison of complete remission, minimal residual disease and survival (event-free and overall) outcomes between 2 arms in first randomisation 2. Comparison of treatment toxicity between two arms in second randomisation  At end of study and at 3 years from close of study
Target Sample Size	Total Sample Size="2240" Sample Size from India="2240"
Phase of Trial	Phase 4
Date of First Enrollment (India) Modification(s)	25/10/2016
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="4" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Open to Recruitment
Publication Details
Brief Summary Modification(s)	The INPOG-ALL-15-01/ ICiCLe-ALL-14 study is a multi-centre randomised open-label parallel group active-controlled study. The principal objective of the study is to improve outcomes in children (1 to 18 years) with newly diagnosed acute lymphoblastic leukaemia (ALL) in India. Children enrolled on the study will receive uniform contemporary risk-adapted treatment based on standardised assessment of tumour cytogenetics and minimal residual disease (MRD) burden. The goal is to use these criteria to decrease treatment related toxicities in children at low risk of relapse. Randomisation is performed to investigate the impact of two interventions that will constitute the primary outcome measure. The first randomisation (R1) will investigate the impact on toxicity outcomes, of a shorter course (3 weeks versus 5 weeks) of the corticosteroid prednisolone (dosed at 60mg/m2/day) during the induction treatment phase in patients with standard and intermediate risk B-cell precursor ALL. The second randomisation (R2) will examine the impact on survival outcomes, of introducing Mitoxantrone (1 dose, 10mg/m2) in place of Doxorubicin (3 doses, 30mg/m2/dose) during the delayed intensification phase in all newly diagnosed patients. Secondary outcome measures will evaluate remission (microscopy and MRD remission) and survival outcomes in R1 randomised patients as well as toxicity outcomes in R2 randomised patients. Recruitment status of the trial as per 01.05.2019 is 1110 patients enrolled.