Approval Probability
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Also known as AMN107
Nilotinib followed by treatment-free · 1 trial · 1 indication
The primary endpoint was the percentage of participants in major molecular response (MMR) at 48 weeks after initiation of the treatment-free remission (TFR) phase. Participants who required re-initiation of treatment were considered as non-responders.
| Arm | Type | Description |
|---|---|---|
| Nilotinib followed by treatment-free | EXPERIMENTAL | Patients who received a minimum of 2 years of first line nilotinib treatment and with pre-screen PCR results in ≥ MR4.5 entered the consolidation phase of the study (52 weeks - nilotinib 300 mg BID). Patients with Minimal Residual Disease (MRD) at the end of this phase entered the Treatment-Free Remission (TFR) phase where no treatment was given. Non eligible patients will enter the continuation phase of the study. Patients with MRD at the end of the continuation phase will enter the TFR-2 phase of the study where no treatment is given. Non eligible patients will enter the prolonged continuation phase of the study. If at any time during TFR or TFR-2 the patient loses MMR, nilotinib treatment will be immediately re-initiated (nilotinib 300 mg BID). |
| Name | Type | Description |
|---|---|---|
| Nilotinib followed by treatment-free | DRUG | Nilotinib is being used as commercial available capsules (except in Japan where clinical supplies is used) of 150 mg and 200 mg strength. Treatment occurs during consolidation, continuation, prolonged continuation, re-initiation and re-initiation-2 phases of the study. |
Inclusion Criteria: * Male or female patients ≥ 18 years of age * Minimum of 2 calendar years of nilotinib treatment with at least the last 12 months of nilotinib treatment prior to pre-screening at approved total daily dose of 600 mg BID or at a reduced dose of 400 mg QD if required from the persp...
It is a treatment strategy in which chronic myelogenous leukemia patients receive nilotinib, an ABL1 and BCR inhibitor, and then stop treatment to see whether they can maintain remission without ongoing therapy. The approach was studied in a Phase 2 trial of 215 patients with chronic myelogenous leukemia.
Nilotinib targets ABL1 and BCR. It is a small-molecule inhibitor of these targets, which are central to the biology of chronic myelogenous leukemia. By inhibiting ABL1 and BCR, nilotinib suppresses the leukemia cells that drive the disease, and the treatment-free strategy then tests whether that suppression can be maintained after the drug is stopped.
Nilotinib is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating nilotinib followed by treatment-free remission in chronic myelogenous leukemia.
Nilotinib followed by treatment-free remission is in Phase 2 development. It is investigational and is being studied in chronic myelogenous leukemia; it is not described as an approved regimen in this program. The Phase 2 trial has been completed.
The program includes the Phase 2 trial NCT01784068, titled Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients. It enrolled 215 patients aged 18 years and older across the United States, Argentina, Austria, Belgium, Bulgaria, Colombia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Japan, the Netherlands, Poland, Spain, Sweden, and the United Kingdom. The trial is completed.