Status:
COMPLETED
Determining the Maximum Tolerated Dose of Low Dose Interferon-alpha in Conjunction With Nilotinib in Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in pretreated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic...
Eligibility Criteria
Inclusion
- Patients with chronic myeloid leukemia in chronic phase (CML-CP) at screening
- Initial diagnosis of CML cytogenetically confirmed by the presence of the Ph+ metaphases from the bone marrow
- Patients who have been treated with nilotinib for a minimum of 6 months (1 month represents 28 days) after switch from previous CML treatments
- Patients who have been treated with stable dosing of 2x400mg nilotinib within the last month before start of study treatment
- No grade 3-4 CTC toxicities on nilotinib alone in the last month preceding the start of the study regimen
Exclusion
- Patients who are considered Ph- because they do not have a confirmed cytogenetic diagnosis of the t(9;22) translocation in their bone marrow metaphases
- Evidence of a point mutation within the BCR-ABL gene leading to a clinically relevant amino acid exchange in the kinase domain at position T315 (gatekeeper mutation T315I)
- Impaired cardiac function
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01220648
Start Date
April 1 2012
End Date
January 1 2014
Last Update
May 5 2015
Active Locations (1)
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1
Novartis Investigative Site
Leipzig, Germany, 04103