Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia (NCT01914484) | Clinical Trial Compass
CompletedPhase 1/2
Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia
Canada4 participantsStarted 2013-08-01
Plain-language summary
This is the study to test combination regimen of Nilotinib and Ruxolitinib therapy for the treatment of patients with Philadelphia positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL) who is resistant to multiple tyrosine kinase inhibitor therapies with BCR-ABL kinase inhibition activity. Ruxolitinib is a tyrosine kinase inhibitor blocking alternative pathway independent of BCR-ABL mediated pathway, thus having a potential to overcome tyrosine kinase inhibitor resistance in Philadelphia positive CML or ALL patients. Phase I study will be conducted to define a recommended phase II dose (RPTD) and phase II study will examine the hypothesis that combinational approach will increase response rate of resistant CML/ALL patients, thus evaluating efficacy of the combination regimen.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must have Chronic Myeloid Leukemia in any phase (CP, AP, or BP of any phenotype) or Ph+ Acute Lymphoblasic Leukemia. The confirmation of Ph+ chromosome can be substituted by the presence of BCR/ABL transcript by PCR test at diagnosis.
. Patients must be previously treated with and resistant, or intolerant, to 2 or more lines of treatment including imatinib, dasatinib, or other investigational agent. Patient who have CML-CP who were previously treated with and resistant to only dasatinib are also included. At least 2 weeks must have elapsed from the last date of treatment to the first dose of study treatment. Patients who have received Nilotinib for more than 4 consecutive weeks will be excluded.
. Must be ≥18 years old.
. Provide written informed consent.
. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Normal serum levels ≥ LLN (lower limit of normal) or corrected to within normal limits with supplements, prior to the first dose of study medication, of potassium, magnesium and calcium;
Exclusion criteria
. Received Tyrosine Kinase Inhibitor therapy within 7 days prior to receiving the first dose of Ruxolitinib+Nilotinib, with the exception of patients who have previously received Nilotinib who must have stopped Nilotinib 4 weeks prior to receiving the first dose of Ruxolitinib+Nilotinib.
. Patients who received other therapies as follows:
. Underwent autologous or allogeneic stem cell transplant within 60 days prior to receiving the first dose of Ruxolitinib+Nilotinib; any evidence of on-going graft versus-host disease (GVHD), or GVHD requiring immunosuppressive therapy.
. Patients with any of the following:
. Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy.
. Have previously been treated with Ruxolitinib.
. Patients with CML CP are excluded if they are in MCyR.
. Patients with CML AP, CML BP, or Ph+ ALL are excluded if they are in MCyR.