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An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase


Phase 4
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia

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Trial Information

An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase


Inclusion Criteria:



1. patients currrently participating in Novartis study CAMN107A2109

2. imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic
(CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC)

3. males or females ≥18 years of age

4. WHO Performance Status of ≤ 2

5. patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0
x ULN if considered due to tumor

Exclusion Criteria:

1. Impaired cardiac function; use of therapeutic coumarin derivatives

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

3. patients who are pregnant or breast feeding, or adults of reproductive potential not
employing an effective method of birth control

4. patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of
their last dose of chemotherapy

5. ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning
of study drug or who have not recovered from side effects of such therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months

Outcome Time Frame:

3 - 24 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:

CAMN107ABR03

NCT ID:

NCT00786812

Start Date:

August 2008

Completion Date:

January 2012

Related Keywords:

  • Chronic Myeloid Leukemia
  • Leukemia
  • adult chronic myeloid leukemia
  • imatinib
  • nilotinib
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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