Nilotinib + Pegylated Interferon Alpha 2a for Untreated Chronic Phase Chronic Myelogenous Leukemia (NILOPEG)

May 23, 2019 updated by: Hospices Civils de Lyon

"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"

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)
    • Magnesium ≥ LNR.
    • Phosphorus ≥ LNR
    • Calcium ≥ LNR.
  • Negative pregnancy test within the last 7 days for women with childbearing potential.
  • Informed consent signed up
  • Compliance to tretament ensured,
  • Valid social insurance

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
    • Past ventricular or significant auricular tachyarrythmia
    • Clinically significant bradycardia (<50 per minute).
    • QTc (Fredericia) > 450 ms (average on 3 Elektrokardiogramm (EKG)).
    • Myocardial infarction in the last 12 months.
    • Unstable angina within the last 12 months.
    • Other significant cardiac diseases.
  • Other uncontrolled severe disease (such as diabetes melittus etc…)
  • Other ongoing malignant disease.
  • Past history of congenital or acquired clinically significant bleeding disorder.
  • Previous radiotherapy ≥25% of bone marrow.
  • Serious surgery within the past 4 weeks
  • Investigational treatment within the last 30 days prior to day 1.
  • History of non compliance.
  • Cytochrome P450 3A4 (CYP3A4) inhibitors that could not be withdrawn or modified (such as erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil).
  • Severe gastro-intestinal disorders (such as gastric ulcer, uncontrolled nausea, malabsorption syndrome, small intestine resection, gastric shunt).
  • Hepatic, renal or pancreatic chronic disorder unrelated to CML
  • Recent history of acute pancreatitis within a year or history of chronic pancreatic disease .
  • Any concommittant treatment inducing QT prolongation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: nilotinib + pegylated interferon alpha 2a (PEG-IFN).
Drug: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Kinetics of Complete Molecular Response (CMR) at 1, 2, 3, 6, 9, 12, 15, 18 and 24 months.
Time Frame: Patients will be enrolled for 18 months and will be followed for 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.
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
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.
Time Frame: Patients will be enrolled for 18 months and will be followed for 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.
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
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
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
Time Frame: Patients will be enrolled for 18 months and will be followed for 24 months
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
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
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
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
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
Patients will be enrolled for 18 months and will be followed for 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Franck Nicolini, Dr, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009-560

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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