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)
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Myeloid Leukemia
Intervention: Nilotinib, interferon-alfa (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
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 phase (CML-CP).
Clinical Details
Official title: An Open Label, Nonrandomized, Single-center, Phase I Trial of Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP) With Nilotinib in Combination With Low Dose Interferon-alpha (IFN) - NICOLI Study -
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Clinically significant adverse events or abnormal laboratory values (dose-limiting toxicities) unrelated to disease progression, intercurrent illness, or concomitant medications on the combination treatment
Secondary outcome: Rate of major cytogenetic response (MCyR) at 6 and 12 monthsRate of complete cytogenetic response (CCyR) at 6 and 12 months Rate of major molecular response (MMR) at 12 months Safety profile of nilotinib in combination with interferon alfa, i.e. the number of dose limiting toxicities (DLT) for each interferon alfa dose level Progression-free survival (PFS) Event-free survival Overall survival (OS)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Novartis Investigative Site, Leipzig 04103, Germany
Additional Information
Related publications: Guilhot F, Roy L, Saulnier PJ, Guilhot J. Interferon in chronic myeloid leukaemia: past and future. Best Pract Res Clin Haematol. 2009 Sep;22(3):315-29. doi: 10.1016/j.beha.2009.10.005. Review.
Starting date: April 2012
Last updated: May 1, 2015
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