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

Civil Hospices of Lyon

Status and phase: Completed; Phase 2

Conditions: Chronic Myelogenous Leukemia

Treatments: 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT01294618

2009-560

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

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

Experimental group

Treatment:

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.