Front-line treatment of Philadelphia positive (Ph pos), BCR-ABL positive, chronic myeloid leukemia (CML) with two tyrosine kinase inhibitors (TKI) (Nilotinib and Imatinib). A phase II exploratory multicentric study. - GIMEMA CML0408

• Conditions: Philadelphia positive (Ph pos), BCR-ABL positive, Chronic Myeloid Leukemia (CML); MedDRA version: 9.1Level: LLTClassification code 10009013Term: Chronic myeloid leukaemia

• Registration Number: EUCTR2008-004384-19-IT
• Lead Sponsor: G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-28
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patients with a cytologic and cytogenetic confirmed diagnosis of Ph pos CML.
2.Age ≥ 18 years old
3.Early chronic phase (ECP) (within 6 months from diagnosis)
4.No prior treatment with Imatinib for more than 30 days, with a washout period of at least 7 days
5.WHO performance status 0/1
6.Normal serum level of potassium, total calcium corrected for serum albumin, magnesium and phosporus, or correctable with supplements
7.ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to leukaemia.
8.Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukemia.
9.Serum bilirubin ≤ 1.5 x ULN
10.Serum creatinine ≤ 1.5 x ULN
11.Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN.
12.Written informed consent prior to any study procedures being performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Impaired cardiac function, including LVEF < 45% as determined by MUGA scan or echocardiogram, uncontrolled congestive heart failure, uncontrolled hypertension
2.History of myocardial infarction within 12 months, or uncontrolled angina pectoris.
3.Significant electric heart abnormalities, including history or presence of significant ventricular or atrial tachyarrhythmias, congenital long QT syndrome and/or QTc > 450 msec on screening ECG (using the QTcF formula) .
4.History of acute (within one year) or chronic pancreatitis.
5.Impairment of gastrointestinal (GI) function, or a GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
6.Use of therapeutic coumarin derivates (i.e. warfarin, acenocoumarol, phenprocoumon).
7.Acute or chronic liver or renal disease considered unrelated to leukaemia
8.Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
9.Patients who are currently receiving treatment with any of the medications listed in Appendix G and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix G have the potential to prolong QT.
10.Patients who have received Imatinib for more than 30 days, or have been submitted to HSCT.
11.Patients who have received any investigational drug ≤ 4 weeks.
12.Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
13.Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of nilotinib). Post menopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study dr
14.Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory).
15.Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
16.Patients unwilling or unable to comply with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified