Overview

This trial is active, not recruiting.

Condition cml
Treatment amn107
Phase phase 2
Targets PDGF, BCR-ABL, KIT
Sponsor Novartis Pharmaceuticals
Start date August 2013
End date December 2021
Trial size 59 participants
Trial identifier NCT01744665, CAMN107AUS37

Summary

To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
59 patients will be enrolled to the study. Patients who achieve MR4.5 on study will then be randomized to receive a total 2 years (Consolidation Phase) of additional nilotinib therapy. If MR4.5 is sustained during the Consolidation phase, patients will be eligible to stop taking niltoinib during the treatment-free remission (TFR) phase. No head to head comparison of the 2 arms will be performed. Each arm will be compared to historical data.
amn107
Nilotinib will be provided by the sponsor as the study drug. Nilotinib will be provided as 150 mg capsules. Patients will take nilotinib 300mg twice daily on study and dose modifications to 450mg once daily is permitted per protocol.

Primary Outcomes

Measure
Percentage of patients without molecular relapse after stopping nilotinib
time frame: 6 months after stopping nilotinib therapy

Secondary Outcomes

Measure
Percentage of patients without molecular relapse after stopping nilotinib
time frame: 12, 18, and 36 months after stopping nilotinib
Proportion of patients who regain MR4.5 after restarting nilotinib due to molecular relapse
time frame: 7 years
Progression to AP/BC and death where the "failure" event is the earliest occurrence of the following event: progression to AP/BC or death from any cause.
time frame: 7 years
Overall survival (OS) defined as the time from the date of cessation of nilotinib therapy to the date of death from any cause.
time frame: 7 years
Relapse free survival is defined as time from the date of nilotinib treatment discontinuation to the first documented molecular relapse (confirmed loss of MR4.0).
time frame: 7 years
Change in symptom-burden scores by the MDASI-CML assessment
time frame: From baseline to time to when MR4.5 is confirmed and from end of Consolidation Phase to 6 and 12 months into the TFR Phase
Change in healthy utility assessed by EQ-5D-3L
time frame: From baseline to time to when MR4.5 is confirmed and from end of Consolidation Phase to 6 and 12 months into the TFR Phase
Change in patient quality of life assessed by SF-8
time frame: From baseline to time to when MR4.5 is confirmed and from end of Consolidation Phase to 6 and 12 months into the TFR Phase

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of CML - Treated with at least 1 year of imatinib - Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by PCR reported on the International scale. This will be confirmed during screening - Written informed consent obtained prior to any screening procedures performed Exclusion Criteria: - T315I mutation - Prior imatinib failure or had accelerated phase or blast crisis CML - Impaired cardiac function (defined futher in the protocol) - Pregnant or lactating women Other protocol-defined inclusion/exclusion criteria may apply.

Additional Information

Official title A Phase II Randomized, Multicenter Study of Treatment-free Remission in Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Patients Who Achieve and Sustain MR4.5 After Switching to Nilotinib
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Novartis.