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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01933906

Enrollment

Registered

2013-09-02

Start date

2013-08-30

Completion date

2018-11-14

Last updated

2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Phase Chronic Myeloid Leukemia

Keywords

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

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).

Interventions

DRUGP1101

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Efficacy (Number of patients achieving an improvement of remission status)	30 months	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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026