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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nilotinib in conjunction with low dose interferon alfa

Group Type EXPERIMENTAL

Nilotinib, interferon-alfa

Intervention Type DRUG

Interventions

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Nilotinib, interferon-alfa

Intervention Type DRUG

Other Intervention Names

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AMN107

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No