Pegylated Interferon Alfa-2b and Nilotinib for Augmentation of Complete Molecular Response in Chronic Myeloid Leukaemia (PInNACLe)
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|ClinicalTrials.gov Identifier: NCT02001818|
Recruitment Status : Recruiting
First Posted : December 5, 2013
Last Update Posted : May 20, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukaemia||Drug: Nilotinib, Pegylated interferon alpha-2b, Imatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||December 2021|
Experimental: Nilotinib or Imatinib with Peginterferon
Nilotinib 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
Drug: Nilotinib, Pegylated interferon alpha-2b, Imatinib
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.
- level of BCR-ABL [ Time Frame: 24 months of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001818
|Contact: Megan Sanders, PhD||+61 3 9656 firstname.lastname@example.org|
|Australia, South Australia|
|Royal Adelaide Hospital||Recruiting|
|Adelaide, South Australia, Australia, 5000|
|Contact: Tim Hughes, MBBS, MD,FRACP, FRCPA +61 8 822 3330 email@example.com|
|Principal Investigator: Tim Hughes, MBBS, MD, FRACP, FRCPA|
|Principal Investigator:||Tim Hughes, MBBS, MD, FRACP, FRCPA||Royal Adelaide Hospital|
|Principal Investigator:||Andrew Grigg, MBBS, MD, FRACP, FRCPA||Austin Hospital, Melbourne Australia|
|Principal Investigator:||David Yeung, BSc(Med), MBBS(Hons),FRACP||SA Pathology|