Clinical Trials /

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

NCT01933906

Description:

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).

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: AGMT_CML 1
  • SECONDARY ID: 2013-000115-24
  • NCT ID: NCT01933906

Conditions

  • Chronic Phase Chronic Myeloid Leukemia

Interventions

DrugSynonymsArms
P1101PEG-Proline-Interferon alpha-2bP1101

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
P1101ExperimentalP1101 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.
  • P1101

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure:Efficacy (Number of patients achieving an improvement of remission status)
Time Frame:30 months
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Arbeitsgemeinschaft medikamentoese Tumortherapie

Trial Keywords

  • CML
  • Chronic myeloid leukemia
  • Chronic myeloid leukaemia
  • PEG-Proline-Interferon-alpha 2b
  • Interferon
  • P1101
  • Imatinib

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