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

NCT ID: NCT01933906

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-30
• Study Completion Date: 2018-11-14

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).

Conditions

Chronic Phase Chronic Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

P1101

Intervention Type: DRUG

Interventions

P1101

Intervention Type: DRUG

Other Intervention Names

PEG-Proline-Interferon alpha-2b

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AOP Orphan Pharmaceuticals AG

INDUSTRY

Sponsor Role: collaborator

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josef Thaler, MD

Role: STUDY_DIRECTOR

Klinikum Wels-Grieskirchen GmbH

Locations

Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung

Wels, Upper Austria, 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

Countries

Austria

Other Identifiers

2013-000115-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AGMT_CML 1

Identifier Type: -

Identifier Source: org_study_id