Chronic Myeloid Leukemia
Conditions
Keywords
Advanced Disease,, Resistance,, Intolerance
Brief 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.
Interventions
DRUGNilotinib
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study. | between 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response | 24 months |
| To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study | 24 months |
| To follow loss of HR (after previous confirmed HR for AP and CHR for CP) | 3, 6 and 12 months |
Countries
Colombia, Venezuela
Outcome results
None listed