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"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"

Phase 2
18 Years
Open (Enrolling)
Chronic Myelogenous Leukemia

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Trial Information

"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"

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) <

- 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- Cytochrome P450 3A4 (CYP3A4) inhibitors that could not be withdrawn or modified (such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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Franck Nicolini, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospices Civils de Lyon


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

March 2011

Completion Date:

September 2014

Related Keywords:

  • Chronic Myelogenous Leukemia
  • 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
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase