Myelogenous Leukemia
Conditions
Keywords
leukemia, bone marrow, leukemia symptoms, cml, complete blood count, lymphocyte, blood cancer, leukocytes, chronic leukemia, bone marrow biopsy, leukemia research, leukemia cells, bone marrow disease, chronic myeloid leukemia, blood cancer symptoms, white blood cell diseases, chronic myelogenous leukemia, leukemia treatment, leukemia facts, leucemia, facts about leukemia, myelogenous leukemia, newly diagnosed CML, suboptimal response, Philadelphia chromosome positive (Ph+), chronic myelogenous leukemia in chronic phase (CML-CP)
Brief summary
In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Detailed description
This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum patients were treated with imatinib = 6 to \< 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to \< 18 months and having partial cytogenetic response (PCyR), but no CCyR.
Interventions
DRUGImatinib
Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days.
Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase. Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as: * 6 to \< 12 months of treatment and -have 36 - 95% Ph+ metaphases, or * 12 to \<18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics, no FISH \[fluorescence in situ hybridization\] analysis was allowed).
Exclusion criteria
* Patient who have received more than 18 months of imatinib therapy * Patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study. * Prior treatment with greater than 400 mg/day imatinib. * Uncontrolled or significant cardiovascular disease. * Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection). * Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) * Currently taking certain medications that could affect the rhythm of your heart. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib | 12 months | Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durable Complete Cytogenetic Response Rate | 24 months | Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed. |
Countries
Australia, Belgium, Brazil, Czechia, Germany, Italy, Japan, South Korea, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nilotinib (AMN107) Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily. | 2 |
| Imatinib Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations. | 4 |
| Total | 6 |
Baseline characteristics
| Characteristic | Nilotinib (AMN107) | Imatinib | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 4 Participants | 4 Participants |
| Age Continuous | 69.5 years STANDARD_DEVIATION 4.949747 | 45.5 years STANDARD_DEVIATION 12.06924 | 54 years STANDARD_DEVIATION 15.6812 |
| Region of Enrollment Belgium | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Germany | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Japan | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Korea, Republic of | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Poland | 0 participants | 2 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 4 / 4 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 |
Outcome results
Primary
Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Time frame: 12 months
Secondary
Durable Complete Cytogenetic Response Rate
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Time frame: 24 months
Population: The trial was terminated early, so only 6 patients were enrolled.