Clinical trial NCT01131325: Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations
Official title: A Multi-center, Single Arm Study of Nilotinib in Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Patients With Low Imatinib Trough Plasma Concentrations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: CML
Philadelphia Chromosome Positive (Ph+)
Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
Keywords: Philadelphia chromosome positive
Ph+
chronic myelogenous leukemia chronic phase
CML-CP
low imatinib trough levels
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.


Eligibility criteria: Inclusion Criteria:

* Cytogenetically confirmed Ph+ CML-CP Any prior dose of Imatinib
* Imatinib 400 mg daily for ≥7 consecutive days prior to imatinib trough collection
* Imatinib trough plasma concentration \<850 ng/mL

Exclusion Criteria:

* Prior documented failure events as defined by ELN guidelines:
* Loss of CHR, CCyR, or clonal progression/Ph+
* Less than CHR at 3 months after diagnosis
* No CyR at 6 months after diagnosis
* Less than PCyR at 12 months after diagnosis
* Less than CCyR at 18 months after diagnosis
* Prior accelerated phase or blast phase CML
* Previously documented T315I mutation
* Previous treatment for CML with any other tyrosine kinase inhibitor except for imatinib
* Patients who had any other treatment for CML (transplant) except interferon +/- ara- C, imatinib, hydroxyurea and/or anagrelide
* Impaired cardiac function
* Patients receiving therapy with strong inhibitors of CYP3A4 or medications that prolong the QT interval and cannot be either discontinued or switched to a different medication prior to starting study drug.
* Any other malignancy that is clinically significant or requires active intervention.
* Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery
* Treatment with other investigational agents within 30 days of Day 1
* Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of nilotinib
* Sexually active male and female patients taking nilotinib unwilling to use adequate contraception throughout the trial and 3 months following discontinuation of study drug

Primary outcomes:
measure: Number of Treatment Failure Events up to 2 Years
timeFrame: up to 2 years
Secondary outcomes:
measure: European LeukemiaNet (ELN)-Defined Optimal Responses
timeFrame: up to 2 years
measure: Loss of Complete Cytogenetic Response (CCyR), Major Molecular Response (MMR) and Complete Molecular Response (CMR) on Nilotinib
timeFrame: up to 2 years
measure: Duration of Complete Cytogenetic Response (CCyR), Major Molecular Response (MMR) and Complete Molecular Response (CMR)Achieved on Nilotinib
timeFrame: up to 2 years
measure: Event-free Survival (EFS), Progression-free Survival (PFS) and Overall Survival (OS) up to 2 Years
timeFrame: up to 2 years
measure: European LeukemiaNet (ELN)-Defined Suboptimal Events
timeFrame: up to 2 years
measure: Number of Participants Reported Adverse Events
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada CCC of Nevada (1)
state: Nevada
city: Amarillo
country: United States
facility: Cancer Center of the High Plains
state: Texas
city: Dallas
country: United States
facility: Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (2)
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: