Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response

Overview

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).

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 14, 2018

Interventions

  • Drug: P1101

Arms, Groups and Cohorts

  • Experimental: P1101
    • P1101 50µg s.c. will be administered every 2 weeks in addition to preexisting imatinib treatment. In the absence of dose limiting toxicities after 12 weeks, the dose will be escalated to 100µg every 2 weeks. Maximum treatment duration will not expand 18 months.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients ≥ 18 years of age – BCR-ABL positive chronic myeloid leukaemia in chronic phase treated with imatinib as first line therapy – CHR, CCyR after at least 18 months of imatinib treatment – Adequate organ function, defined as the following: – total bilirubin < 1.5 x ULN, – AST and ALT < 2.5 x ULN, – creatinine < 1.5 x ULN, – ANC > 1.5 x 109/L, – platelets > 100 x 109/L – Written, voluntarily signed informed consent Exclusion Criteria:

  • CMR (molecular remission 4.5 or BCR-ABL transcripts undetectable) – Patient has received any other investigational treatment within 28 days before study entry – Treatment with a second generation tyrosine kinase inhibitor (dasatinib, nilotinib) – ECOG performance status ≥ 3 – Patients with a primary of a different histological origin than the study indication (unless relapse-free interval is ≥ 5 years, except cervical carcinoma, basal cell epithelioma or squamous cell carcinoma of the skin) – Evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease etc.) – Acute chronic infections – Known autoimmune disease (e.g. collagen disease, polyarthritis, immune thrombocytopenia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder) – Female patients who are pregnant or breast-feeding – Known diagnosis of HIV

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Arbeitsgemeinschaft medikamentoese Tumortherapie
  • Collaborator
    • AOP Orphan Pharmaceuticals AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Josef Thaler, MD, Study Director, Klinikum Wels-Grieskirchen GmbH

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