A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

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

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-04-30

Brief Summary

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A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.

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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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nilotinib

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

Interventions

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Nilotinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Stratum 1:

1. Currently participating in Novartis study CAMN107A2109
2. Written signed and dated informed consent prior to any study procedures being performed

Stratum 2:

1. Male or female
2. \> 18 years
3. ECOG 0,1,2
4. ASL/ALT \<= 2.5 ULN or \<= 5.0 ULN
5. Alcaline Phosfatase \<= 2.5 ULN
6. Serum Bilirrubin \<= 1.5 ULN
7. Serum Creatinine \<= 1.5 ULN or creatinine clearance \>=50 ml/min / 24 hours
8. Serum Lipase \<= 1.5 ULN

Exclusion Criteria

Stratum 1 and stratum 2:

1. Reduction of the cardiac function
2. Use of Coumadin
3. Other severe medical concurrent conditions
4. Treatment with medications that prolonged the QT interval.
5. Mayor surgery 15 days before the inclusion in the protocol
6. Pregnant women or lactation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No