Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Nilotinib followed by treatment-free is an investigational small molecule being studied for Chronic Myelogenous Leukemia (CML). It is designed to be administered as nilotinib therapy and then followed by a treatment-free period, aiming to assess whether patients can maintain remission without continued treatment.
Nilotinib followed by treatment-free is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical research on this regimen for Chronic Myelogenous Leukemia.
Nilotinib followed by treatment-free is in Phase 2 clinical development. It is an investigational regimen and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with no active trials currently ongoing.
Nilotinib followed by treatment-free has one completed clinical trial, NCT01784068, titled 'Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients.' This Phase 2 study enrolled 215 participants across multiple countries including the United States, Argentina, and Japan.
Nilotinib followed by treatment-free is a regimen that involves the drug nilotinib, but it is not simply the drug itself. It refers to a treatment strategy where nilotinib is given initially and then discontinued to observe treatment-free remission. This approach is being studied specifically in Chronic Myelogenous Leukemia.