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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 -


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Chronic Myeloid Leukemia

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Trial Information

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 -


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107ADE10

NCT ID:

NCT01220648

Start Date:

April 2012

Completion Date:

March 2014

Related Keywords:

  • Chronic Myeloid Leukemia
  • 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
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

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