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

Primary Purpose

Chronic Phase Chronic Myeloid Leukemia

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
P1101
Sponsored by
Arbeitsgemeinschaft medikamentoese Tumortherapie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Phase Chronic Myeloid Leukemia focused on measuring CML, Chronic myeloid leukemia, Chronic myeloid leukaemia, PEG-Proline-Interferon-alpha 2b, Interferon, P1101, Imatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung
  • Universitätskliniken Innsbruck, Univ.-Klinik f.Innere Medizin V Hämtologie u. Onkologie
  • Ordensklinikum Linz - Elisabethinen
  • Universitätsklinikum der PMU Salzburg, Universitätsklinik für Innere Medizin III

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

P1101

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 29, 2013
Last Updated
January 3, 2019
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
AOP Orphan Pharmaceuticals AG
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1. Study Identification

Unique Protocol Identification Number
NCT01933906
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 30, 2013 (Actual)
Primary Completion Date
November 14, 2018 (Actual)
Study Completion Date
November 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
AOP Orphan Pharmaceuticals AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Phase Chronic Myeloid Leukemia
Keywords
CML, Chronic myeloid leukemia, Chronic myeloid leukaemia, PEG-Proline-Interferon-alpha 2b, Interferon, P1101, Imatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P1101
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
P1101
Other Intervention Name(s)
PEG-Proline-Interferon alpha-2b
Primary Outcome Measure Information:
Title
Number and seriousness of adverse events to evaluate safety and tolerability
Description
The primary objective is to determine the safety and tolerability of the addition of P1101 to the pre-study established dose of imatinib.
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Efficacy (Number of patients achieving an improvement of remission status)
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.
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Thaler, MD
Organizational Affiliation
Klinikum Wels-Grieskirchen GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung
City
Wels
State/Province
Oberösterreich
ZIP/Postal Code
4600
Country
Austria
Facility Name
Universitätskliniken Innsbruck, Univ.-Klinik f.Innere Medizin V Hämtologie u. Onkologie
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Ordensklinikum Linz - Elisabethinen
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Universitätsklinikum der PMU Salzburg, Universitätsklinik für Innere Medizin III
City
Salzburg
ZIP/Postal Code
5020
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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