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An Open-label, Multicenter Study Providing Continuation of Nilotinib in Adult Patients With Imatinib-(Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase


Phase 3
18 Years
60 Years
Not Enrolling
Both
Chronic Myeloid Leukemia

Thank you

Trial Information

An Open-label, Multicenter Study Providing Continuation of Nilotinib in Adult Patients With Imatinib-(Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase


Inclusion Criteria:



- Having participated in Novartis study CAMN107A2109, and

- Written signed and dated informed consent prior to any study procedures being
performed.

Exclusion Criteria:

- Impaired cardiac function,

- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol,
phenprocoumon) up to the day before study drug administration; Other concurrent
severe and/or uncontrolled medical conditions,

- Patients who are currently receiving treatment with any of the medications that have
the potential to prolong the QT interval,

- patients who have undergone a major surgery and have not recovered from side effects
of such therapy within 15 days,

- Patients who are pregnant or breast feeding or adults of reproductive potential not
employing an effective method of birth control, OR

- Patients unwilling or unable to comply with the protocol.

Other protocol -defined inclusion/exclusion criteria may apply

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Mexico: Federal Commission for Sanitary Risks Protection

Study ID:

CAMN107AMX01

NCT ID:

NCT00905593

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Chronic Myeloid Leukemia
  • chronic myeloid leukemia,
  • blast crisis,
  • accelerated phase,
  • nilotinib,
  • imatinib,
  • resistant,
  • intolerant,
  • chronic phase
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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