Clinical Trial Details

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Study ID ISAV
Investigator
Carlo Gambacorti-Passerini, MD,   Azienda Ospedaliera San Gerardo di Monza
Anna D'Emilio, MD,   Ospedale S. Bortolo (USSL 6)
Francesco Di Raimondo, MD,   Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele"
Elisabetta Abruzzese, MD,   Università di Tor Vergata Ospedale di S. Eugenio
Ester Orlandi, MD,   IRCCS Policlinico San Matteo Pavia
Valeria Santini, MD,   Università di Firenze Azienda Ospedaliera-Universitaria Careggi
Bruno Martino, MD,   A.O. Bianchi-Melacrino-Morelli
Alessandra Iurlo, MD,   Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Arnon Nagler, MD,   Chaim Sheba Medical Center
Enrica Morra, MD,   Ospedale Niguarda Ca' Granda
Philipp le Coutre, MD,   Charité University of Berlin
Sarit Assouline, MD,   McGill University - Jewish General Hospital
Onno Leeskma, MD,   Onze Lieve Vrouwe Gasthuis
Pilar Giraldo, MD,   Hospital Universitario Miguel Servet
Ivana Pierri, MD,   IRCCS A.O.U. San Martino
Title Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients
Conditions Chronic Myeloid Leukemia
Interventions Drug: Imatinib mesylate
Phase Phase 4
Purpose The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
Inclusion Criteria: 1. Signed and dated IRB/IEC-approved Informed Consent 2. Age>=18 years 3. Male or female patients with CML diagnosed in chronic or accelerated phase and who have been treated for more than 2 consecutive years with imatinib therapy 4. Sustained Complete Molecular Response (as defined by the treating center) for at least 18 months with imatinib treatment 5. A minimum of 3 CMR determined by Q-RT-PCR analysis to support disease status, with the list one performed within 3 calendar months prior to enrollment date 6. Willingness and ability to comply with scheduled visits laboratory tests and other study procedures Exclusion Criteria: 1. Allogenic hematopoietic stem cell transplantation 2. Known active infections including human immunodeficiency virus (HIV) positivity 3. Current enrollment another clinical trial 4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results
Study Location
McGill University - Jewish General Hospital Division of Hematology and Department of Oncology
Montréal, Quebec, H3T 1E2
Contact N/A

Information objtained from ClinicalTrials.gov, on 10/20/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578213


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