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Phase 2
18 Years
65 Years
Not Enrolling
Chronic Phase of Chronic Myeloid Leukemia

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Trial Information

Inclusion Criteria:

1. Signed Written Informed Consent.

2. Target Population

a)18 to 65 years b)Newly diagnosed (≤ 3 months) Philadelphia chromosome positive
chronic CP-CML c)Major BCR-ABL transcripts d)Not previously treated for CML except
with hydroxyurea or anagrelide e)ECOG Performance Status≤ 2 f)Adequate Organ
Function. i)Total bilirubin< 2.0 times the institutional Upper Limit of Normal
ii)Hepatic enzymes(AST, ALT )≤ 2.5 ULN iii)Serum Na, K+, Mg2+ and Ca2+ > Lower Limit
of Normal (LLN) or supplemented iv)Serum Creatinine< 1.5 ULN g)Women of childbearing
potential (WOCBP) must be using an adequate method of contraception.

3. Free subject, without guardianship nor subordination,

4. Health insurance coverage. -

Exclusion Criteria:

1. Patients with BCR-ABL other than M-BCR-ABL, Philadelphia negative CML.

2. Patients previously treated with Tyrosine Kinase Inhibitors (TKIs).

3. Medical history and concurrent diseases :

1. Hypersensitivity to any of the excipients of dasatinib

2. Prior treatment with Interferon-α, contraindication to interferon-α,
hypersensitivity to any of the excipients of PegIFNα2b,

3. Concomitant immunosuppressive treatment or corticosteroids,

4. Preexisting thyroid disease unless it is controlled with conventional treatment,
Auto-immune thyroiditis,

5. Autoimmune disorder, Chronic liver disease,

6. Prior or ongoing severe psychiatric disease,

7. Epilepsy or compromised central nervous system(CNS) function,

8. HIV positivity, chronic hepatitis B or C,

9. Uncontrolled or significant cardio vascular or pulmonary disease,

i)Uncontrolled angina, myocardial infarction or congestive heart failure within 6
months, ii)Echocardiography with LVF < 45% or LLN, peak velocity of tricuspid
regurgitant flow > 2,8 m/s iii)Pulmonary arterial hypertension (PAH), iv)Any history
of clinically significant ventricular or supraventricular arrhythmias, v)Diagnosed
congenital long QT syndrome, vi)Prolonged QTc interval > 450 msec (Fredericia) on 3
pre-entry electrocardiogram, vii)Subjects with hypokalemia or hypomagnesemia if it
cannot be corrected, j)Other malignant disease during the last 5 years prior to the
inclusion except basal cell carcinoma of the skin or carcinoma in situ of the cervix,
k)History of significant bleeding disorder unrelated to CML, including: i)Diagnosed
congenital bleeding disorders (e.g. von Willebrand's disease), ii)Ongoing or recent
(≤ 3 months) significant gastrointestinal bleeding. l)Another severe or life
-threatening medical disease.

4. Women who are pregnant or breastfeeding, WOCBP who are unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period and for at least 4
weeks after the last dose of study drug.

5. Prohibited treatments and/or therapies:

1. strong inhibitors of the CYP3A4,

2. category I drugs that are generally accepted to have a risk of causing "Torsades
de Pointes", Patients must discontinue the drug minimum 7 days prior to starting

6. History /any condition for poor compliance to the treatment.

7. Inability to freely provide consent through judiciary or administrative condition.

8. Ongoing participation to another study.

Type of Study:


Study Design:


Outcome Measure:

Cumulative rate of molecular response

Outcome Description:

Molecular response 4.5 (MR4.5) is defined by either a positive BCR-ABL/ABL ratio ≤ 0.0032 on the international scale or by undetectable BCR-ABL with the analysis of at least 32000 copies of ABL (according to the ELN recommendations by N. Cross et al., leukemia 2012). Centralized analyses of molecular response by RTQPCR will be performed for all molecular assessments in this study.

Outcome Time Frame:

at 12 months.

Principal Investigator

Lydia ROY, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Poitiers University Hospital


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

Completion Date:

Related Keywords:

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