Spots Global Cancer Trial Database for Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia
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Trial Identification
Brief Title: Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia
Official Title: Front-line Treatment of Philadelphia Positive (Ph Pos), BCRABL Positive, Chronic Myeloid Leukemia (CML) With Two Tyrosine Kinase Inhibitors (TKI) (Nilotinib and Imotinib) A Phase II Exploratory Multicentric Centre.
Study ID: NCT00769327
Conditions
Study Description
Brief Summary: RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia.
Detailed Description: OBJECTIVES: Primary * To assess the complete cytogenetic response rate at 12 months in patients with Philadelphia chromosome- and BCR-ABL-positive early chronic phase chronic myelogenous leukemia treated with nilotinib and imatinib mesylate. Secondary * To assess the complete cytogenetic response rate at 6 and 24 months in these patients. * To assess the major and complete molecular response rate at 6, 12, and 24 months in these patients. * To assess the frequency and the types of BCR-ABL kinase domain mutations at 24 months during and for 3 years after study treatment. * To assess the rate of failures and the time to failure at 12, 24, and 60 months in these patients. * To assess compliance, toxicity, and adverse events in these patients. * To understand the relationship between response, gene expression profile, biomarkers, and drug plasma concentrations in these patients. OUTLINE: This is a multicenter study. Patients receive oral nilotinib twice daily in months 1-3, 7-9, 13-15, and 19-21 and oral imatinib mesylate once daily in months 4-6, 10-12, 16-18, and 22-24. Treatment continues for 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible to continue oral nilotinib and oral imatinib mesylate for up to another 36 months if it is in the interest of the patient. Blood samples and bone marrow biopsies are collected periodically for cytogenetic response by chromosome banding analysis and FISH analysis; real-time quantitative PCR mutational analysis and single nucleotide polymorphism analysis of BCR-ABL transcripts; and gene expression profiling and correlative biomarker studies. After completion of study therapy, patients are followed every 6 months for 3 years and then every 12 months for 5 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centro Oncologico Basilicata, Rionero in Vulture, Potenza, Italy
Ospedale Civile Alessandria, Alessandria, , Italy
Dipartimento Area Medica P.O., Ascoli Piceno, , Italy
S.G. Moscati Hospital, Avellino, , Italy
Unità Operativa Ematologia 1 - Università degli Studi di Bari, Bari, , Italy
Ospedali Riuniti di Bergamo, Bergamo, , Italy
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli, Bologna, , Italy
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO, Cagliari, , Italy
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania, Catania, , Italy
Unità di Oncoematologia Azienda Ospedaliera Garibaldi, Catania, , Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia, Catanzaro, , Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna, Ferrara, , Italy
Azienda Ospedaliera di Firenze, Firenze, , Italy
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria, Foggia, , Italy
Clinica Ematologica - DiMI - Università degli Studi di Genova, Genova, , Italy
Clinica Ematologica - Università degli Studi, Genova, , Italy
A.O. Universitaria Policlinico Martina di Messina, Messina, , Italy
Azienda ospedaliera Ospedali Riuniti "Papardo Piemonte", Messina, , Italy
Sez. di medicina Interna Oncologia ed Ematologia, Modena, , Italy
Universtià degli Studi di Napoli "Federico II" - Facoltà di medicina e chirurgia, Napoli, , Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro, Novara, , Italy
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga, Orbassano, , Italy
Ospedali Riuniti "Villa Sofia-Cervello", Palermo, , Italy
U.O. Ematologia Clinica - Azienda USL di Pescara, Pescara, , Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza, Piacenza, , Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli", Reggio Calabria, , Italy
Unità operativa complessa di Ematologia, Reggio Emilia, , Italy
A.O Umberto I, Roma, , Italy
Complesso Ospedaliero S. Giovanni Addolorata, Roma, , Italy
Ospedale S.Eugenio, Roma, , Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese, Siena, , Italy
Azienda ospedaliera S. Maria di Terni, Terni, , Italy
SCDO Ematologia 2 AOU S.Giovanni Battista, Torino, , Italy
Policlinico Universitario Udine, Udine, , Italy
Policlinico G. B. Rossi - Borgo Roma, Verona, , Italy
Ospedale San Bortolo, Vicenza, , Italy
Contact Details
Name: Michele Baccarani, MD
Affiliation: Gruppo Italiano Malattie EMatologiche dell'Adulto
Role: PRINCIPAL_INVESTIGATOR
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