Chronic Phase Chronic Myeloid LeukemiaPhase 1NCT01933906
Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response
A Phase 1 study testing P1101 in people with Chronic Phase Chronic Myeloid Leukemia, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 4 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Phase Chronic Myeloid Leukemia
- What is being tested?
- P1101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesAustria
- Study dates
- 30 Aug 2013to 14 Nov 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- creatinine < 1.5 x ULN,
- ANC > 1.5 x 109/L,
- platelets > 100 x 109/L
- Written, voluntarily signed informed consent
Who cannot join
- 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.)
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- 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
Trial locations and contacts
4 sites in 1 country.
Austria4 sites
Universitätskliniken Innsbruck, Univ.-Klinik f.Innere Medizin V Hämtologie u. Onkologie
Innsbruck, A-6020
Ordensklinikum Linz - Elisabethinen
Linz, A-4020
Universitätsklinikum der PMU Salzburg, Universitätsklinik für Innere Medizin III
Salzburg, 5020
Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung
Wels, Upper Austria, 4600
About this study
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)
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
- Being tested
- P1101
- Keywords
- CML, Chronic myeloid leukemia, Chronic myeloid leukaemia, PEG-Proline-Interferon-alpha 2b, Interferon, P1101, Imatinib
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1101Drug
Also called PEG-Proline-Interferon alpha-2b
| Study group | Role | What they receive |
|---|---|---|
| P1101 | Experimental | 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. Receives: Drug: P1101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and seriousness of adverse events to evaluate safety and tolerability
The primary objective is to determine the safety and tolerability of the addition of P1101 to the pre-study established dose of imatinib.
Measured: 30 months
Secondary outcomes (1)
Efficacy (Number of patients achieving an improvement of remission status)
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.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study start30 Aug 2013
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Phase Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Sponsor type
- University, hospital or other
- Collaborators
- AOP Orphan Pharmaceuticals AG
- Responsible party
- Sponsor
- Investigators
- Josef Thaler, MD, Study director, Klinikum Wels-Grieskirchen GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933906
- Sponsor's protocol ID
- AGMT_CML 1
- Other IDs
- 2013-000115-24
- Status last verified
- Jan 2019
- First submitted
- 29 Aug 2013
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01933906
- Acronym / sponsor ID
- AGMT_CML 1
- Conditions
- Chronic Phase Chronic Myeloid Leukemia
- Keywords
- CML, Chronic myeloid leukemia, Chronic myeloid leukaemia, PEG-Proline-Interferon-alpha 2b, Interferon, P1101, Imatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese TumortherapieUniversity, hospital or other
- Collaborators
- AOP Orphan Pharmaceuticals AG
- Study start
- 30 Aug 2013 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P1101 | Experimental | Drug: P1101P1101 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Written, voluntarily signed informed consent
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P1101Also: PEG-Proline-Interferon alpha-2b | Drug | P1101 |
Primary outcome
Number and seriousness of adverse events to evaluate safety and tolerability
Time frame: 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.
1 secondary outcome
Efficacy (Number of patients achieving an improvement of remission status)
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Thaler, MD study director
Klinikum Wels-Grieskirchen GmbH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P1101 in people with Chronic Phase Chronic Myeloid Leukemia, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 4 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and seriousness of adverse events to evaluate safety and tolerability (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.