Spots Global Cancer Trial Database for Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response
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Trial Identification
Brief Title: Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response
Official Title: Phase 1 Study to Evaluate the Feasibility and Efficacy of the Addition of P1101 (PEG-Proline-Interferon Alpha-2b) to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response (MR 4.5 or BCR-ABL Transcripts Not Detectable)
Study ID: NCT01933906
Conditions
Interventions
Study Description
Brief Summary: In this phase I pilot study, it is planned to investigate the feasibility and safety of adding an interferon therapy to an preexisting imatinib treatment in patients with chronic phase chronic myeloid leukaemia. The participating patients have already reached a response during their imatinib therapy (CCyR) but have still a detectable disease (no molecular response MR 4.5 or better).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung, Wels, Oberösterreich, Austria
Universitätskliniken Innsbruck, Univ.-Klinik f.Innere Medizin V Hämtologie u. Onkologie, Innsbruck, , Austria
Ordensklinikum Linz - Elisabethinen, Linz, , Austria
Universitätsklinikum der PMU Salzburg, Universitätsklinik für Innere Medizin III, Salzburg, , Austria
Contact Details
Name: Josef Thaler, MD
Affiliation: Klinikum Wels-Grieskirchen GmbH
Role: STUDY_DIRECTOR
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