A study of safety and effect of adding a low dose of interferon to dasatinib in patients with newly diagnosed chronic myeloid leukemia (CML)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

Inclusion Criteria:
1.Age =18- 70 years of age
2.Diagnosis of chronic myeloid leukemia in chronic phase (CML-CP) associated with BCR-ABL1 quantifiable by RQ-PCR (IS)
3.No other current or planned anti-leukemia therapies excluding hydroxyurea treatment for up to two months.
4.ECOG Performance status 0,1, or 2
5.Adequate organ function as defined by: Total bilirubin < 1.5 x ULN (ULN = upper limit of normal in a local institution lab) in absence of Gilbert genotype; ASAT and ALAT < 2.5 x ULN. Creatinine < 2x ULN. Potassium, magnesium and phosphate not below LLN (LLN= lower level of normal)
6.Life expectancy of more than 12 months in the absence of any intervention
7.Patient has given written informed consent to participate in the study

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Prior accelerated phase or blast crisis
2.Uncontrolled or significant cardiovascular disease, including any of the following:
a.A myocardial infarction within 6 months
b.Uncontrolled angina within 3 months
c.Congestive heart failure within 3 months
d.Diagnosed or suspected congenital long QT syndrome
e.Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe)
f.Prolonged QTcF interval > 450 msec on pre-entry ECG
3.Atypical BCR-ABL1 transcript not quantifiable by RQ-PCR.
4.Another primary malignant disease, which requires systemic treatment (chemotherapy or radiation)
5.Severe and/or life-threatening medical disease including acute liver disease
6.History of significant congenital or acquired bleeding disorder unrelated to cancer
7.Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dasatinib
8.Patients actively receiving therapy with strong CYP3A4 inhibitors and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug
9.Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug
10.Female patients who are: pregnant, breast feeding or potentially fertile without a negative pregnancy test prior to baseline or unwilling to use contraception on trial
11.History of non-compliance, abuse of alcohol, illicit drugs, severe psychiatric disorders or other inability to grant informed consent.
12.Hypersensitivity to any interferon preparation;
13.Autoimmune hepatitis or a history of autoimmune disease;
14.Pre-existing thyroid disease unless it can be controlled with conventional treatment;
15.Epilepsy and/or compromised central nervous system (CNS) function;
16.HCV/HIV patients
17. Depression requiring treatment
18. Known or suspected hypersensitivity to dasatinib or any of its excipients
19. Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucraseisomaltase insufficiency

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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