The aim of this study is to demonstrate the safety and the efficacy of a combination of 2 treatments shown to have some efficacy in Chronic Phase Chronic Myelogenous Leukemia (CP CML) separately, but that have never been combined to date, and this combination is expected to substantially increase the molecular response rates.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Combination of both treatments active by different means on the leukemic cells, in order to enhance the response rates of CP CML patients since diagnosis.
Hospices Civils de Lyon
Lyon, France
Cumulative incidence of complete molecular remissions after 12 months of treatment with nilotinib + Pegylated Interferon (PEG-IFN)
The trial opens for enrolment in 2011 March 7th for 18 months. Each patient will be followed for 24 months after entry.
Time frame: 24 months
Kinetics of Complete Molecular Response (CMR) at 1, 2, 3, 6, 9, 12, 15, 18 and 24 months.
CMR corresponds to a level of BCR-ABL transcripts \< 0.001 % (BCR-ABL/ABL ratio \< 0.001%). The BCR-ABL/ABL ratio will be analysed by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at 1, 2, 3, 6, 9, 12, 15, 18 and 24 months to study kinetics of CMR.
Time frame: Patients will be enrolled for 18 months and will be followed for 24 months
Stability of CMR : Proportion of patients maintaining their CMR at 18 and 24 months
Time frame: Patients will be enrolled for 18 months and will be followed for 24 months
Kinetics of Major Molecular Response (MMR) at 1, 2, 3, 6, 9, 12, 15, 18 and 24 months.
MMR corresponds to a level of BCR-ABL transcripts \< 0.1 % (BCR-ABL/ABL ratio \< 0.1%). The BCR-ABL/ABL ratio is analysed by RT-PCR at 1, 2, 3, 6, 9, 12, 15, 18 and 24 months to study kinetics of MMR.
Time frame: Patients will be enrolled for 18 months and will be followed for 24 months
Stability of MMR : proportion of patients maintaining their MMR at 18 and 24 months
Time frame: Patients will be enrolled for 18 months and will be followed for 24 months
Cumulative Complete Cytogenetic Remission (CCyR) rates at 3, 6 and 12 months.
Time frame: Patients will be enrolled for 18 months and will be followed for 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Safety (hematologic and non-hematologic) of the combination nilotinib + PEG-IFN
Time frame: Patients will be enrolled for 18 months and will be followed for 24 months
Dose reductions or interruptions of each treatment studied
Time frame: Patients will be enrolled for 18 months and will be followed for 24 months
Progression free survival.
Time frame: Patients will be enrolled for 18 months and will be followed for 24 months
Overall survival.
Time frame: Patients will be enrolled for 18 months and will be followed for 24 months
Quality of life on nilotinib + PEG-IFN
Time frame: Patients will be enrolled for 18 months and will be followed for 24 months
Event free survival.
Time frame: Patients will be enrolled for 18 months and will be followed for 24 months