A Phase 3 interventional study of Imatinib and Nilotinib (AMN107) in Myelogenous Leukemia, sponsored by Novartis Pharmaceuticals. Terminated at 80 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-06.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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).
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 6 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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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:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Drug: Nilotinib (AMN107)
Drug: Imatinib
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.
Also known as: STI571, imatinib mesylate, Glivec®, Gleevec®
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.
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
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
| Milestone | Nilotinib (AMN107) | Imatinib |
|---|---|---|
| Started | 2 | 4 |
| Completed | 2 | 4 |
| Not completed | 0 | 0 |
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
No measurements were reported for this outcome.
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nilotinib (AMN107) | — | 0/2 (0%) | 2/2 (100%) |
| Imatinib | — | 0/4 (0%) | 4/4 (100%) |
| Event | Nilotinib (AMN107) | Imatinib |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/2 | 0/4 |
| Arthropod biteInjury, poisoning and procedural complications | 1/2 | 0/4 |
| ConstipationGastrointestinal disorders | 1/2 | 0/4 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/2 | 0/4 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/2 | 1/4 |
| FatigueGeneral disorders | 1/2 | 0/4 |
| HeadacheNervous system disorders | 0/2 | 2/4 |
| Hepatic function abnormalityHepatobiliary disorders | 1/2 | 0/4 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 0/2 | 2/4 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/2 | 0/4 |
| Age, Categorical(Participants) | Nilotinib (AMN107) | Imatinib | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 4 | 4 |
| >=65 years | 2 | 0 | 2 |
| Age Continuous(years) | Nilotinib (AMN107) | Imatinib | Total |
|---|---|---|---|
| Mean | 69.5 ± 4.949747 | 45.5 ± 12.06924 | 54 ± 15.6812 |
| Sex: Female, Male(Participants) | Nilotinib (AMN107) | Imatinib | Total |
|---|---|---|---|
| Female | 1 | 3 | 4 |
| Male | 1 | 1 | 2 |
| Region of Enrollment(participants) | Nilotinib (AMN107) | Imatinib | Total |
|---|---|---|---|
| Belgium | 1 | 0 | 1 |
| Germany | 0 | 1 | 1 |
| Japan | 1 | 0 | 1 |
| Korea, Republic of | 0 | 1 | 1 |
| Poland | 0 | 2 | 2 |
This study is terminated, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals