Molecular Monitoring of Minimal Residual Disease in Chronic Myeloid Leukemia

Project location: Italy, Rome
Project start date: December 2011 - Project end date: December 2012
Project number: 2011-43
Beneficiary: A.PRO.TI.ON. Onlus


The success of tyrosine kinase inhibition of the BCR-ABL fusion gene with imatinib in the treatment of chronic myeloid leukemia (CML) has resulted in the use of molecular detection techniques for routine clinical management. Current clinical guidelines recommend the use of molecular testing of BCR-ABL transcript levels by quantitative real-time transcriptase polymerase chain reaction (qRT-PCR) every 3 to 6 months.
Molecular monitoring is a key component of the management of patients with chronic myeloid leukemia. The current recommendation is that molecular monitoring be performed in place of cytogenetic assessment when a major molecular response (MMR) is achieved. With the more potent kinase inhibitors nilotinib and dasatinib now approved as front-line therapy, more patients will achieve an MMR and will benefit from molecular monitoring. There is a strong correlation between certain BCR-ABL1 levels and the cytogenetic response, which means that molecular monitoring may act as a surrogate for cytogenetic response, but only if the BCR-ABL1 values are converted to the international reporting scale. Furthermore, improvements in the limit of BCR-ABL1 detection and reduction of intra-assay variability are ongoing issues of importance for molecular monitoring. Standardization of molecular methods to accurately assess the patient response also remains a challenge, despite the recent certification of international scale reference materials.

The research team will evaluate minimal residual disease in 85 patients affected by chronic myeloid leukaemia (CML).
The team will perform it by quantitative RT-PCR according to Europe against cancer guidelines (Leukemia 2003; 17: 2318) which describe the gold standard method of monitoring patients with CML.

This project received a grant from the NPF. Participation in these study protocols will ensure patients have access to a wider range of treatment options and the possibility of being subjected to the most innovative therapies among those accredited in the international scientific community.

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