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)

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 -

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01220648

Acronym

NICOLI

Enrollment

Registered

2010-10-14

Start date

2012-04-30

Completion date

2014-01-31

Last updated

2015-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic myeloid leukemia, interferon alfa, nilotinib, combination, CML, Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP) after switch from previous CML treatment

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 phase (CML-CP).

Interventions

DRUGNilotinib, interferon-alfa

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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	12 months

Secondary

Measure	Time frame
Rate of complete cytogenetic response (CCyR) at 6 and 12 months	12 months
Rate of major molecular response (MMR) at 12 months	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	12 months
Rate of major cytogenetic response (MCyR) at 6 and 12 months	12 months
Event-free survival	12 months
Overall survival (OS)	12 months
Progression-free survival (PFS)	12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026