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) (NICOLI)

Novartis

Status and phase

Completed

Phase 1

Conditions

Chronic Myeloid Leukemia

Treatments

Drug: Nilotinib, interferon-alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT01220648

CAMN107ADE10

2010-022006-40 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No 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/exclusion criteria may apply