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

Phase 1

Completed

• Conditions: Chronic Phase Chronic Myeloid Leukemia
• Interventions: Drug: P1101

• Registration Number: NCT01933906
• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-08-29
• Study Start: 2013-08-30
• Study First Posted: 2013-09-02
• Primary Completion: 2018-11-14
• Study Completion: 2018-11-14
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
P1101	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung; 🇦🇹 Wels, Oberösterreich, Austria

Universitätskliniken Innsbruck, Univ.-Klinik f.Innere Medizin V Hämtologie u. Onkologie; 🇦🇹 Innsbruck, Austria

Universitätsklinikum der PMU Salzburg, Universitätsklinik für Innere Medizin III; 🇦🇹 Salzburg, Austria

Ordensklinikum Linz - Elisabethinen; 🇦🇹 Linz, Austria