Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive), Chronic Myelogenous Leukemia
Conditions
Keywords
Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Brief summary
This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.
Interventions
DRUGNilotinib
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed as Ph+ ALL who are either relapsed after or refractory to standard therapy * Diagnosed as CML in blast crisis or accelerated phase or chronic phase who are resistant or intolerant to imatinib * Performance status is normal or ambulatory and capable of all self-care
Exclusion criteria
* A history of significant or serious uncontrolled cardiovascular disease * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of nilotinib * Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation assessed by dose limiting toxicity within first cycle of 28 day treatment and AEs within 3 cycles | every first 28 days |
| Pharmacokinetic (PK) profile of single and multiple doses | day 1 and 15 of cycle 1,day 6, 8, 10, 12, 22 and 28 of cycle 1, day 15 of cycle 2 |
Secondary
| Measure | Time frame |
|---|---|
| Anti-leukemic activity within 3 cycles of 28 days treatment | Day 28 cycle 1, 2 and 3, at the time of disease progression, and at the time of study completion |
| Bone marrow and/or blood assessments to detect the presence of Bcr-Abl transcript and mutational analysis of Bcr-Abl before, during and after therapy. | Day 28 cycle 1, 2 and 3, at the time of disease progression, and at the time of study comp |
Countries
Japan
Outcome results
None listed