CML09 | The Australasian Leukaemia and Lymphoma Group

A Phase II study in adult patients with newly diagnosed chronic-phase chronic myeloid leukaemia of initial intensified imatinib therapy and sequential dose-escalation followed by treatment with nilotinib in suboptimal responders to determine the rate and duration of major molecular response

DOI number	10.58109/zn0q-1b28
Publisher	Australasian Leukaemia and Lymphoma Group (ALLG)
Creator(s)	Australasian Leukaemia and Lymphoma Group (ALLG) Timothy Hughes (Institute of Medical and Veterinary Science)
Date Made Available	2023
Dataset	Individual participant data (IPD) in aggregate form
Description of Dataset	Dataset includes Data for 210 patients with newly diagnosed CML, introducing TKI in a sequential and randomised way. Demographic data Diagnostic data Treatment data Outcome data
Funding	Australasian Leukaemia and Lymphoma Group (ALLG)
Subject (ANZSRC Category)	Cancer therapy (excl. chemotherapy and radiation therapy) Molecular targets
ANZCTR Reference	ACTRN12607000325404
Publication(s)	BCR-ABL1 doubling times more reliably assess the dynamics of CML relapse compared with the BCR-ABL1 fold rise: implications for monitoring and management Distribution of genomic breakpoints in chronic myeloid leukemia: analysis of 308 patients Early molecular response and female sex strongly predict stable undetectable BCR-ABL1, the criteria for imatinib discontinuation in patients with CML TIDEL-II: first-line use of imatinib in CML with early switch to nilotinib for failure to achieve time-dependent molecular targets A Method for Next-Generation Sequencing of Paired Diagnostic and Remission Samples to Detect Mitochondrial DNA Mutations Associated with Leukemia BCR-ABL1 genomic DNA PCR response kinetics during first-line imatinib treatment of chronic myeloid leukemia Gene expression signature that predicts early molecular response failure in chronic-phase CML patients on frontline imatinib
Dataset Access	Access can be requested via the Health Data Australia catalogue. Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to info@allg.org.au