Spots Global Cancer Trial Database for Treatment of Adult Ph+ LAL With BMS-354825
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Trial Identification
Brief Title: Treatment of Adult Ph+ LAL With BMS-354825
Official Title: A Phase II Multicenter Study on the Treatment of Adult de Novo Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) With the Protein Tyrosine Kinase Inhibitor BMS-354825. EudraCT Number 2005-005107-42.
Study ID: NCT00391989
Conditions
Interventions
Study Description
Brief Summary: The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate.
Detailed Description: This open label phase II study of Dasatinib will enroll adult de novo Ph+ ALL patients. A minimum of 48 cases will be required to complete the study. Accrual is expected to be completed in 18 months. The study will be considered completed for patients in HCR after completion of a total of 12 weeks of treatment. After completion patients will go off study and will be treated according to the best treatment option for Ph+ ALL patients in 1st HCR. The enrollment in the post-remissional phase of the current GIMEMA LAL protocol will be suggested.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ospedale Sant'Anna-17, Ronciglione, Viterbo, Italy
Nuovo Ospedale "Torrette", Ancona, , Italy
Ospedale San Donato USL 8, Arezzo, , Italy
Presidio Ospedaliero "C. e G.Mazzoni", Ascoli Piceno, , Italy
Università degli Studi di Bari, Bari, , Italy
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli, Bologna, , Italy
Azienda Spedali Civili, Brescia, , Italy
Osp. Reg. A. Di Summa, Brindisi, , Italy
Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi, Cagliari, , Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto", Catania, , Italy
Azienda Ospedaliera Pugliese Ciaccio, Catanzaro, , Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna, Ferrara, , Italy
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino", Genova, , Italy
Ospedale Niguarda " Ca Granda", Milano, , Italy
Sez. di medicina Interna Oncologia ed Ematologia, Modena, , Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Div. TERE, Napoli, , Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli", Napoli, , Italy
Ematologia Università Federico II, Napoli, , Italy
Ospedale S. Luigi Gonzaga, Orbassano, , Italy
Dip. Oncologico "La Maddalena", Palermo, , Italy
Div. di Ematologia - A.O. "V. Cervello", Palermo, , Italy
Università degli Studi di Palermo - A.U. Policlinico, Palermo, , Italy
Div. di Ematologia IRCCS Policlinico S. Matteo, Pavia, , Italy
U.O. Ematologia Clinica - Azienda USL di Pescara, Pescara, , Italy
Istituto di Ematologia- Ospedale San Carlo, Potenza, , Italy
Ospedale S.Maria delle Croci, Ravenna, , Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli", Reggio Calabria, , Italy
Ospedale S. Camillo, Rome, , Italy
Ospedale S.Eugenio, Rome, , Italy
Università Cattolica del Sacro Cuore, Rome, , Italy
Università degli Studi di Roma "La Sapienza", Rome, , Italy
Università degli Studi di Tor Vergata, Rome, , Italy
Ospedale Casa Sollievo della sofferenza, San Giovanni Rotondo, , Italy
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia, Sassari, , Italy
Policlinico Universitario, Udine, , Italy
Policlinico G.B. Rossi, Verona, , Italy
Contact Details
Name: Robin Foà, MD, PhD
Affiliation: Università degli Studi di Roma "La Sapienza", Dipartimento di Biotecnologie Cellulari ed Ematolgia
Role: PRINCIPAL_INVESTIGATOR
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