ICiCLe - NCG

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Title	POG ALL-15-01 ICiCLe ALL 14 Study - A collaborative, multicentre, national study for newly diagnosed patients with acute lymphoblastic leukemia-a randomised open label phase III/IV study (ICiCLe) Study design / Type : Open label Randomised Phase III/IV trial
Principal Investigator	Dr. Vaskar Saha
Participating Centres	Tata Medical Center, Kolkata Tata Memorial Hospital, Mumbai Postgraduate Institute of Medical Education and Research, Chandigarh IRCH- Department of Medical Oncology, All India Institute of Medical Sciences -New Delhi Department of Pediatrics- All India Institute of Medical Sciences, New Delhi Cancer Institute, Adyar, Chennai
Number of participants	2240
Status	Ongoing
Synopsis	ICiCLe-ALL-14 is a collaborative, multicentre, randomised, open label study for newly diagnosed patients with acute lymphoblastic leukemia (ALL). The main objectives of the study are to standardize treatment of childhood ALL across India, decrease treatment related mortality and improve overall outcomes. Patients with B-Cell precursor ALL are risk stratified at diagnosis based on clinical, genetic and Prednisolone response into standard (SR), Intermediate (IR) and High (HR) risk. There are two randomisations. In induction, SR and IR (age <10 years) are randomised to either 3 or 5 weeks of steroid therapy. In delayed intensification, all patients are eligible to be randomised to receive either one dose of Mitoxantrone or 3 doses of Doxorubicin. Primary objective for the first randomisation is toxicity and secondary is survival. For the second randomisation, primary objective is survival and secondary is toxicity. Recruitment targets are 2240 and 1800 respectively for the first and second randomisations.

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