Spots Global Cancer Trial Database for Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients
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Trial Identification
Brief Title: Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients
Official Title: Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients (ISAV)
Study ID: NCT01578213
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: This study will recruit approximately 100 CML patients under imatinib therapy in complete molecular remission with a history of at least 18 months of consecutive negative standard Q-RT-PCR as performed in their own centers. After signing the informed consent form (ICF), the patients will be tested for dPCR and will discontinue imatinib therapy. Then they will be monitored by standard Q-RT-PCR to assess the maintenance of the molecular remission; collection of data will be prospective as each center will collect the data for 36 months. At the end of this period, a peripheral blood sample for dPCR analysis will be obtained from those patients who will still have undetectable BCR-ABL transcripts by Q-RT-PCR to verify CML eradication. The maintenance of molecular remission by Q-RT-PCR and the survival will be monitored every six months during an additional follow-up of 24 months. Patients found to be positive to BCR-ABL transcripts by standard Q-RTPCR will repeat the test every 2 to 4 weeks until the loss of molecular remission, defined as two consecutive BCR-ABL positive tests with at least one with BCR-ABL/BCR value above 0.1%, or until the end of the study, whichever come first.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
McGill University - Jewish General Hospital Division of Hematology and Department of Oncology, Montréal, Quebec, Canada
Charité University of Berlin - Clinic of Medicine - Hematology and Oncology, Berlin, , Germany
Chaim Sheba Medical Center - Division of Hematology, BMT and CBB, Tel Hashomer, , Israel
Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele", Catania, Italy/Catania, Italy
Università di Firenze Azienda Ospedaliera - Universitaria Careggi, Firenze, Italy/Firenze, Italy
Azienda Ospedaliera San Gerardo di Monza, Monza, Italy/MB, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC di Ematologia, Milano, Italy/Milano, Italy
IRCCS Policlinico San Matteo Pavia - Istituto di Ematologia, Pavia, Italy/Pavia, Italy
A.O. Bianchi-Melacrino-Morelli U.O. Ematologia, Reggio Calabria, Italy/Reggio Calabria, Italy
Universita di Tor Vergata Ospedale S. Eugenio, Rome, Italy/Rome, Italy
Ospedale S. Bortolo (USSL 6), Vicenza, Italy/Vicenza, Italy
Ospedale Niguarda Ca' Granda - U.O. Ematologia, Milano, MI, Italy
IRCCS A.O.U. San Martino, Genova, , Italy
Hospital Universitario Miguel Servet - Hematologia, Zaragoza, , Spain
Contact Details
Name: Carlo Gambacorti-Passerini, MD
Affiliation: Azienda Ospedaliera San Gerardo di Monza
Role: STUDY_DIRECTOR
Name: Eros Di Bona, MD
Affiliation: Ospedale S. Bortolo (USSL 6)
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Di Raimondo, MD
Affiliation: Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele"
Role: PRINCIPAL_INVESTIGATOR
Name: Elisabetta Abruzzese, MD
Affiliation: Università di Tor Vergata Ospedale di S. Eugenio
Role: PRINCIPAL_INVESTIGATOR
Name: Luca Arcaini, MD
Affiliation: IRCCS Policlinico San Matteo Pavia
Role: PRINCIPAL_INVESTIGATOR
Name: Valeria Santini, MD
Affiliation: Università di Firenze Azienda Ospedaliera-Universitaria Careggi
Role: PRINCIPAL_INVESTIGATOR
Name: Bruno Martino, MD
Affiliation: A.O. Bianchi-Melacrino-Morelli
Role: PRINCIPAL_INVESTIGATOR
Name: Alessandra Iurlo, MD
Affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Role: PRINCIPAL_INVESTIGATOR
Name: Arnon Nagler, MD
Affiliation: Chaim Sheba Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Ester Pungolino, MD
Affiliation: Ospedale Niguarda Ca' Granda
Role: PRINCIPAL_INVESTIGATOR
Name: Philipp le Coutre, MD
Affiliation: Charité University of Berlin
Role: PRINCIPAL_INVESTIGATOR
Name: Sarit Assouline, MD
Affiliation: McGill University - Jewish General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Onno Leeskma, MD
Affiliation: Onze Lieve Vrouwe Gasthuis
Role: PRINCIPAL_INVESTIGATOR
Name: Marcio Andrade, MD
Affiliation: Hospital Miguel Servet
Role: PRINCIPAL_INVESTIGATOR
Name: Micaela Bergamaschi, MD
Affiliation: IRCCS A.O.U. San Martino
Role: PRINCIPAL_INVESTIGATOR
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