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 ]

The primary objective is to determine the safety and tolerability of the addition of P1101 to the pre-study established dose of imatinib.


Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy (Number of patients achieving an improvement of remission status) [ Time Frame: 30 months ]

Secondary objective is to determine the rate of achievement of ≥ 1 log reduction from the initial BCR-ABL transcript level at study entry and the achievement of molecular remission 4.5 or undetectable BCR-ABL transcripts.


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