Clinical Trial: Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Mye
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 Summary:
Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Current Primary Outcome: Number and seriousness of adverse events to evaluate safety and tolerability [ Time Frame: 30 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Efficacy (Number of patients achieving an improvement of remission status) [ Time Frame: 30 months ]
Original Secondary Outcome: Same as current
Information By: Arbeitsgemeinschaft medikamentoese Tumortherapie
Dates:
Date Received: August 29, 2013
Date Started: August 2013
Date Completion: December 2019
Last Updated: December 22, 2016
Last Verified: December 2016