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Chronic Myeloid LeukaemiaPhase 2PInNACLeNCT02001818

Pegylated Interferon Alfa-2b and Nilotinib for Augmentation of Complete Molecular Response in Chronic Myeloid Leukaemia

A Phase 2 study testing Nilotinib, Pegylated interferon alpha-2b, Imatinib in people with Chronic Myeloid Leukaemia, run by Australasian Leukaemia and Lymphoma Group at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The treatment of CML and the expected survival has been revolutionised since the introduction of tyrosine kinase inhibitors (TKIs) such as nilotinib. Despite their effectiveness, these drugs will never totally remove CML affected cells from the body. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukaemia
What is being tested?
Nilotinib, Pegylated interferon alpha-2b, Imatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteAustralia
Study dates
11 Apr 2014to 7 Jan 2022
Phase
Phase 2
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

  • All of the following criteria must be satisfied for enrolment in the study.
  • Post-pubertal male or female patients aged 18 years or above.
  • Newly diagnosed (within Three months of study entry) Ph+ CML-Chronic Phase with a quantifiable "breakpoint cluster region - Abelson murine leukemia" (BCR-ABL) transcript
  • No prior therapy for CML and no other current anti-leukaemic therapies (other than prior or current treatment with hydroxyurea or anagrelide).
  • No signs of extramedullary leukaemia, except for hepatosplenomegaly.
  • Documented chronic-phase CML as defined by:
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  • <15% blasts in both the peripheral blood and bone marrow ii. <30% blasts and promyelocytes in both the peripheral blood and bone marrow iii. <20% basophils in the peripheral blood iv. Platelet count >100 × 109/L (Note: Patients will be considered to be in chronic phase if their platelet count is ≤ 100 x 109/L as a result of treatment with hydroxyurea or anagrelide provided that all of the other criteria for chronic phase CML are met).
  • Eastern Cooperative Oncology Group Performance Status score ≤2 (see Appendix 2)
  • Patients must have the following laboratory values:
  • Potassium level > Lower Limit of Normal (LLN)
  • Calcium (corrected for serum albumin) > Lower Limit of Normal (LLN)
  • Magnesium level > Lower Limit of Normal (LLN)
  • Phosphorus > Lower Limit of Normal (LLN)
  • ALT and AST < 2.5 × ULN or < 5.0 × Upper limit of normal (ULN) if considered due to tumour
  • ALP < 2.5 × Upper limit of normal (ULN) unless considered due to tumour
  • Bilirubin < 1.5 × Upper limit of normal (ULN) unless due to Gilbert's syndrome
  • Creatinine < 1.5 × Upper limit of normal (ULN)
  • Amylase and lipase < 1.5 × Upper limit of normal (ULN) Note: Biochemical abnormalities that resolve after corrective measures pose no impediment to re-screening.
  • Female patients of childbearing potential must have a negative serum pregnancy test within one week prior to study entry OR have been amenorrhoeic for at least 12 months.
  • All patients of reproductive potential must agree to use birth control for the duration of the study. This is only required for as long as the patient has reproductive potential. The type of birth control is a decision which should be made between the treating clinician and the patient.
  • 9.Life expectancy of more than 12 months. 10.Patient has given written, informed consent to participate in the study (which includes consent to obtain samples for the correlative study except in a rare case where a site does not have the capacity to participate in the correlative study).

Who cannot join

  • Presence of any of the following criteria will exclude the subject from enrolment in the study.
  • Patients who have previously received radiotherapy to >25% of their bone marrow.
  • Patients who have undergone major surgery within the 4 weeks prior to study entry or have not recovered from earlier surgery.
  • Impaired cardiac function, including any of the following:
  • Inability to monitor the QT/corrected QT intervak (QTc) interval on ECG
  • Long QT syndrome or a known family history of long QT syndrome.
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  • Resting bradycardia (<50 beats per minute) suspected to be secondary to cardiac pathology
  • QTc > 450 msec on baseline ECG (using the QTc formula). If QTc >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc
  • Other clinically significant uncontrolled heart disease (e.g. congestive heart failure or uncontrolled hypertension)
  • History of or presence of clinically significant ventricular or atrial tachyarrhythmias, including atrial fibrillation
  • History of arterial vascular disease including coronary artery disease (Angina, myocardial infarction), cerebrovascular disease (Transient ischaemic attacks and strokes), peripheral vascular disease, retinal artery thromboses and mesenteric arterial thromboses.
  • Treatment with agents (other than warfarin) that prolong QT interval or inhibit Cytochrome P450 3A4 (CYP3A4), unless judged to be clinically essential.
  • Another primary malignant disease, except for such conditions that do not currently require treatment, lesions that can be or had been completely excised (eg Skin Cancers) and neoplasms that does not significantly affect long term survival of the patient
  • Significantly impaired GI function or GI disease that may alter nilotinib absorption.
  • Other concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, uncontrolled or unstable thyroid disease, active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol.
  • History of confirmed acute or chronic pancreatitis.
  • Cytopathologically confirmed Central Nervous System(CNS) infiltration. [In the absence of suspicion of CNS involvement, lumbar puncture is not required.]
  • Patients unwilling or unable to comply with protocol and patients with a history of noncompliance or inability to grant informed consent.
  • Known diagnosis of human immunodeficiency virus (HIV) infection.
  • Prior allogeneic stem cell transplantation
  • Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. Male and female patients of childbearing potential must agree to employ an effective method of birth control throughout the study. The type of birth control is a decision which should be made between the treating clinician and the patient
  • Known history of uncontrolled depression or any other psychiatric disease likely to be exacerbated by study treatment. A formal psychiatric assessment at baseline is not required.
  • Current participation in another therapeutic clinical trial (participation in clinical trials that do not involve active interventions is not an exclusion for the study.)
  • Previous adverse reaction to the trial drug/s

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: Phase II Study of Nilotinib Plus Pegylated Interferon Alfa-2b as First-line Therapy in Chronic Phase Chronic Myelogenous Leukaemia Aiming to Maximize Complete Molecular Response and Major Molecular Response.

The treatment of CML and the expected survival has been revolutionised since the introduction of tyrosine kinase inhibitors (TKIs) such as nilotinib. Despite their effectiveness, these drugs will never totally remove CML affected cells from the body. In order to achieve this goal, and potentially enable CML patients to live without the daily need for TKIs, other features of the patient's immune system may need to be harnessed. One possibility is using externally administered interferon (IFN) to augment the response induced by the TKI.

This study will assess the response in terms of length of survival, detection of minimal disease levels and time until disease worsens in patients with chronic phase CML who are taking nilotinib and pegylated Interferon. Patients will commence taking nilotinib for 3 months, and once tolerated, will simultaneously be treated with injected pegIFN for up to 2 years. Patients can continue taking nilotinib beyond this time providing they are receiving benefit. Options are available for patients to decrease or increase their dose or to switch to another TKI, imatinib, to ensure a balance between drug effectiveness and minimal side effects is achieved.

Being tested
Nilotinib, Pegylated interferon alpha-2b, Imatinib
Medical subject headings
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.

  • Nilotinib, Pegylated interferon alpha-2b, ImatinibDrug

    All patients joining the study will receive treatment with oral nilotinib at 300mg twice daily. This will be given as monotherapy for 3 months initially, prior to commencement of combination therapy with Pegylated interferon alpha-2b added to nilotinib. Patients intolerant of nilotinib will have the option of switching to imatinib.

Study groups in NCT02001818
Study groupRoleWhat they receive
Nilotinib or Imatinib with PeginterferonExperimentalNilotinib 300mg twice daily for 24 months. Pegylated interferon alpha-2b 30-50 micrograms subcutaneously once weekly for maxium 21 months (3 months after trial registration). Patients intolerant of nilotinib may be switched to appropriate doses of imatinib
Receives: Drug: Nilotinib, Pegylated interferon alpha-2b, Imatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. level of BCR-ABL

    Measured: 24 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2013 (estimated)
  2. Study start11 Apr 2014
  3. Primary completion7 Jan 2022
  4. Study completion7 Jan 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02001818
Sponsor's protocol ID
CML11
Other IDs
ACTRN12612000851864
Acronym
PInNACLe
Status last verified
Aug 2024
First submitted
12 Nov 2013
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nilotinib, Pegylated interferon alpha-2b, Imatinib in people with Chronic Myeloid Leukaemia, run by Australasian Leukaemia and Lymphoma Group at 1 site in Australia.

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 21 inclusion and 24 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

level of BCR-ABL (time frame: 24 months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02001818.

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 6 Aug 2024.

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