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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Imatinib Mesylate

Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply