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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Chronic Phase Chronic Myeloid Leukemia

Intervention / Treatment
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* Drug: P1101


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P1101<br>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. | Drug: P1101<br> <br> * Other names: PEG-Proline-Interferon alpha-2b;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and seriousness of adverse events to evaluate safety and tolerability | The primary objective is to determine the safety and tolerability of the addition of P1101 to the pre-study established dose of imatinib. | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (Number of patients achieving an improvement of remission status) | 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. | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CML, Chronic myeloid leukemia, Chronic myeloid leukaemia, PEG-Proline-Interferon-alpha 2b, Interferon, P1101, Imatinib