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

Chronic Phase Chronic Myeloid Leukemia Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT01933906
• Other study ID #: AGMT_CML 1
• Secondary ID: 2013-000115-24
• Status: Completed
• Phase: Phase 1
• Start date: August 30, 2013
• Est. completion date: November 14, 2018

Study information

• Verified date: January 2019
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 14, 2018
• Est. primary completion date: November 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Phase Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Drug:
• P1101

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie	AOP Orphan Pharmaceuticals AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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