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

NCT01294618 | Completed Phase 2 DMC

• 1 other identifier: 2009-560
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myelogenous Leukemia

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

Outcome Measures

Primary Outcomes (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.

  24 months

Secondary Outcomes (11)

• 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

• 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

• 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

Study Arms (1)

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

EXPERIMENTAL

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.

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69003, France

Location

Related Publications (1)

• 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.

  PMID: 26687426 RESULT

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Franck Nicolini, Dr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 11, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2013
• Last Updated: May 28, 2019

Record last verified: 2011-02

Locations

FR (1)