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

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie (Other)

Overall Status

Completed

CT.gov ID

NCT01933906

Collaborator

AOP Orphan Pharmaceuticals AG (Industry)

Enrollment

Locations

Arm

62.5

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Phase Chronic Myeloid Leukemia	Drug: P1101	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Aug 30, 2013

Actual Primary Completion Date :

Nov 14, 2018

Actual Study Completion Date :

Nov 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: P1101 Other Names: PEG-Proline-Interferon alpha-2b

Arm

Intervention/Treatment

Experimental: 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.

Drug: P1101

Other Names:

PEG-Proline-Interferon alpha-2b

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung	Wels	Oberösterreich	Austria	4600
2	Universitätskliniken Innsbruck, Univ.-Klinik f.Innere Medizin V Hämtologie u. Onkologie	Innsbruck		Austria	A-6020
3	Ordensklinikum Linz - Elisabethinen	Linz		Austria	A-4020
4	Universitätsklinikum der PMU Salzburg, Universitätsklinik für Innere Medizin III	Salzburg		Austria	5020