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THE IMATINIB LONG TERM SIDE EFFECTS (ILTE) STUDY IS AN OBSERVATIONAL PROTOCOL ON THE LONG TERM SIDE EFFECTS OF IMATINIB IN CML PATIENTS IN CYTOGENETIC REMISSION.
ILTE IS AN INDEPENDENT, GLOBAL STUDY.
TWENTY CENTERS FROM ITALY, FRANCE, GERMANY,
KOREA, U.S. AND CANADA ALREADY PARTICIPATE IN ILTE.
THE PROTOCOL IS ALSO PART OF ELN-EUROPEAN LEUKEMIA NETWORK (DELIVERABLE 4.40 IN WP04).
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| THE ILTE STEERING COMMITTEE INCLUDES: |
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SARIT ASSOULINE MD, MCGILL UNIVERSITY, MONTREAL, CANADA. |
| MICHAEL W.N. DEININGER, MD, PHD, OREGON HEALTH AND SCIENCE UNIVERSITY, PORTLAND US. |
| CARLO GAMBACORTI, MD, UNIVERSITY OF MILANO BICOCCA, MONZA, ITALY (COORDINATOR). |
| FRANCOIS GUILHOT, MD, CLINICAL RESEARCH CENTER UNIVERSITY HOSPITAL, POITIERS, FRANCE. |
| DONG-WOOK KIM, MD, PHD, THE CATHOLIC UNIVERSITY OF KOREA, SEUL. |
| PHILIPP LE COUTRE, MD, CHARITE� UNIVERSITY, BERLIN, GERMANY. |
| ENRICA MORRA, MD, OSPEDALE CA' GRANDA, ITALY. |
| ARNON NAGLER MD, CHAIM SHEBA MEDICAL CENTER,TEL HASHOMER, ISRAEL. |
| FABRIZIO PANE, MD, UNIVERSITY OF NAPLES, ITALY. |
| GIUSEPPE SAGLIO, MD, UNIVERSITY OF TURIN, ITALY. |
| MARIAGRAZIA VALSECCHI, PHD, UNIVERSITY OF MILANO BICOCCA, MONZA, ITALY. |
CML patients who started imatinib between 1999 and 2004, and were in CCyR after two years of therapy are eligible. |
| The ILTE study is focused on two main and related goals: |
| it will evaluate the occurrence of long term side effects, including the development of second cancers, utilizing the oldest cohort of CML patients treated with imatinib and using both a retrospective and a prospective collection of data; |
| it will identify among patients with negative PCR results, those that could be considered "true negative", using a new �PCR card� assay. |
ILTE is an independent, non company sponsored study and is funded by AIFA (Italian Drug Safety Agency) and Regione Lombardia, direzione sanità.
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