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Chronic Myelogenous LeukemiaPhase 2NILOPEGNCT01294618

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

A Phase 2 study testing 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. in people with Chronic Myelogenous Leukemia, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myelogenous Leukemia
What is being tested?
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.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
Mar 2011to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hospices Civils de Lyon

    Lyon, 69003

Other trials in France

About this study

Official title: "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.

Being tested
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.
Keywords
Chronic Myelogenous Leukemia, nilotinib, pegylated interferon, BCR-ABL Philadelphia chromosome, Hematologic, cytogenetic and molecular response rates and kinetics will be studied in addition to the safety of the combination
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.Drug

    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.

Study groups in NCT01294618
Study groupRoleWhat they receive
nilotinib + pegylated interferon alpha 2a (PEG-IFN).ExperimentalNot described
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months

Secondary outcomes (11)

  1. 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.

    Measured: Patients will be enrolled for 18 months and will be followed for 24 months

  2. Stability of CMR : Proportion of patients maintaining their CMR at 18 and 24 months

    Measured: Patients will be enrolled for 18 months and will be followed for 24 months

  3. 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.

    Measured: Patients will be enrolled for 18 months and will be followed for 24 months

  4. Stability of MMR : proportion of patients maintaining their MMR at 18 and 24 months

    Measured: Patients will be enrolled for 18 months and will be followed for 24 months

  5. Cumulative Complete Cytogenetic Remission (CCyR) rates at 3, 6 and 12 months.

    Measured: Patients will be enrolled for 18 months and will be followed for 24 months

  6. Safety (hematologic and non-hematologic) of the combination nilotinib + PEG-IFN

    Measured: Patients will be enrolled for 18 months and will be followed for 24 months

  7. Dose reductions or interruptions of each treatment studied

    Measured: Patients will be enrolled for 18 months and will be followed for 24 months

  8. Progression free survival.

    Measured: Patients will be enrolled for 18 months and will be followed for 24 months

  9. Overall survival.

    Measured: Patients will be enrolled for 18 months and will be followed for 24 months

  10. Quality of life on nilotinib + PEG-IFN

    Measured: Patients will be enrolled for 18 months and will be followed for 24 months

  11. Event free survival.

    Measured: Patients will be enrolled for 18 months and will be followed for 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionMar 2011
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01294618
Sponsor's protocol ID
2009-560
Acronym
NILOPEG
Status last verified
Feb 2011
First submitted
7 Feb 2011
Last updated
28 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Nicolini FE, Etienne G, Dubruille V, Roy L, Huguet F, Legros L, Giraudier S, Coiteux V, Guerci-Bresler A, Lenain P, Cony-Makhoul P, Gardembas M, Hermet E, Rousselot P, Ame S, Gagnieu MC, Pivot C, Hayette S, Maguer-Satta V, Etienne M, Dulucq S, Rea D, Mahon FX. Nilotinib and peginterferon alfa-2a for newly diagnosed chronic-phase chronic myeloid leukaemia (NiloPeg): a multicentre, non-randomised, open-label phase 2 study. Lancet Haematol. 2015 Jan;2(1):e37-46. doi: 10.1016/S2352-3026(14)00027-1. Epub 2015 Jan 7.

    PubMed 26687426

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 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. in people with Chronic Myelogenous Leukemia, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of complete molecular remissions after 12 months of treatment with nilotinib + Pegylated Interferon (PEG-IFN) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01294618, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.

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