"Phase II Multicenter Study Evaluating the Efficacy and the Safety of a Combination of Nilotinib Plus Pegylated Interferon Alpha 2a for de Novo Chronic Phase Chronic Myelogenous Leukemia Patients"

Hospices Civils de Lyon1 site in 1 country60 target enrollmentMarch 2011

InterventionsNilotinib,Novartis,300 mg twice a day +Pegylated interferon 2a,Roche, 45 microg weekly starting Month 2-Month 12 or beyond according to investigator choice.

DrugsNilotinib,Novartis,300 mg twice a day +Pegylated interferon 2a,Roche, 45 microg weekly starting Month 2-Month 12 or beyond according to investigator choice.

Overview

Phase: Phase 2
Intervention: Nilotinib,Novartis,300 mg twice a day +Pegylated interferon 2a,Roche, 45 microg weekly starting Month 2-Month 12 or beyond according to investigator choice.
Conditions: Chronic Myelogenous Leukemia
Sponsor: Hospices Civils de Lyon
Enrollment: 60
Locations: 1
Primary Endpoint: Cumulative incidence of complete molecular remissions after 12 months of treatment with nilotinib + Pegylated Interferon (PEG-IFN)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

September 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Performans status 0-2
•CP CML diagnosed since less than 3 months without previous Tyrosine Kinase Inhibitor (TKI) or interferon treatment
•Adequate organic functions:
•Total Bilirubin \< 1.5xUpper Normal Range (UNR).
•Aspartate Amino Transferase (ASAT) and Alanine Amino Transferase (ALAT) \< 2.5xUNR.
•Alkaline phosphatase ≤ 2.5xUNR
•Amylase and lipase ≤ 1.5xUNR.
•Creatininemia \< 1.5xUNR.
•Biological blood standards :
•Potassium ≥ Lower Normal Range (LNR)

Exclusion Criteria

•Prior TKI or interferon treatment for the CML
•Contra-indication to IFN
•Pregnancy, breast feeding
•Human Immunodeficiency Virus positive, chronic hepatitis B or C.
•Other BCR-ABL transcript than M-bcr
•Cardiopathy defined as:
•Left Ventricular Ejection Fraction (LVEF) \< 45%.
•Left bundle branch block
•Ventricular pacemaker.
•Congenital prolonged QT

Arms & Interventions

nilotinib + pegylated interferon alpha 2a (PEG-IFN).

Intervention: Nilotinib,Novartis,300 mg twice a day +Pegylated interferon 2a,Roche, 45 microg weekly starting Month 2-Month 12 or beyond according to investigator choice.

Outcomes

Primary Outcomes

Cumulative incidence of complete molecular remissions after 12 months of treatment with nilotinib + Pegylated Interferon (PEG-IFN)

Time Frame: 24 months

The trial opens for enrolment in 2011 March 7th for 18 months. Each patient will be followed for 24 months after entry.

Secondary Outcomes

Kinetics of Major Molecular Response (MMR) at 1, 2, 3, 6, 9, 12, 15, 18 and 24 months.(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(Patients will be enrolled for 18 months and will be followed for 24 months)
Kinetics of Complete Molecular Response (CMR) at 1, 2, 3, 6, 9, 12, 15, 18 and 24 months.(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(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.(Patients will be enrolled for 18 months and will be followed for 24 months)
Safety (hematologic and non-hematologic) of the combination nilotinib + PEG-IFN(Patients will be enrolled for 18 months and will be followed for 24 months)
Dose reductions or interruptions of each treatment studied(Patients will be enrolled for 18 months and will be followed for 24 months)
Progression free survival.(Patients will be enrolled for 18 months and will be followed for 24 months)
Overall survival.(Patients will be enrolled for 18 months and will be followed for 24 months)
Quality of life on nilotinib + PEG-IFN(Patients will be enrolled for 18 months and will be followed for 24 months)
Event free survival.(Patients will be enrolled for 18 months and will be followed for 24 months)