Clinical trial NCT01933906: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Phase Chronic Myeloid Leukemia
Keywords: CML
Chronic myeloid leukemia
Chronic myeloid leukaemia
PEG-Proline-Interferon-alpha 2b
Interferon
P1101
Imatinib
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: AOP Orphan Pharmaceuticals AG
First posted: 2013-09-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number and seriousness of adverse events to evaluate safety and tolerability
timeFrame: 30 months
Secondary outcomes:
measure: Efficacy (Number of patients achieving an improvement of remission status)
timeFrame: 30 months
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung
state: Oberösterreich
city: Innsbruck
country: Austria
facility: Universitätskliniken Innsbruck, Univ.-Klinik f.Innere Medizin V Hämtologie u. Onkologie
city: Linz
country: Austria
facility: Ordensklinikum Linz - Elisabethinen
city: Salzburg
country: Austria
facility: Universitätsklinikum der PMU Salzburg, Universitätsklinik für Innere Medizin III
Study officials:
affiliation: Klinikum Wels-Grieskirchen GmbH
name: Josef Thaler, MD
role: STUDY_DIRECTOR
References: