Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations (MACS1148)

Novartis

Status and phase

Terminated

Phase 4

Conditions

Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels

CML

Philadelphia Chromosome Positive (Ph+)

Treatments

Drug: nilotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01131325

CAMN107AUS20

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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