Status:
COMPLETED
Combination of Dasatinib and Peg-Interferon Alpha 2b in First Line for Chronic Myeloid Leukemia in Chronic Phase
Lead Sponsor:
Poitiers University Hospital
Conditions:
Chronic Phase of Chronic Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Interferon alpha was a therapy used in Chronic Myeloid Leukemia in Chronic phase prior to the advent of tyrosine kinase inhibitors. Synergistic effect of the combination of Peg-IFNα2a with Imatinib wa...
Eligibility Criteria
Inclusion
- Signed Written Informed Consent.
- 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.
- Free subject, without guardianship nor subordination,
- Health insurance coverage. -
Exclusion
- Patients with BCR-ABL other than M-BCR-ABL, Philadelphia negative CML.
- Patients previously treated with Tyrosine Kinase Inhibitors (TKIs).
- Medical history and concurrent diseases :
- Hypersensitivity to any of the excipients of dasatinib
- Prior treatment with Interferon-α, contraindication to interferon-α, hypersensitivity to any of the excipients of PegIFNα2b,
- Concomitant immunosuppressive treatment or corticosteroids,
- Preexisting thyroid disease unless it is controlled with conventional treatment, Auto-immune thyroiditis,
- Autoimmune disorder, Chronic liver disease,
- Prior or ongoing severe psychiatric disease,
- Epilepsy or compromised central nervous system(CNS) function,
- HIV positivity, chronic hepatitis B or C,
- 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.
- 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.
- Prohibited treatments and/or therapies:
- strong inhibitors of the CYP3A4,
- 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 dasatinib.
- History /any condition for poor compliance to the treatment.
- Inability to freely provide consent through judiciary or administrative condition.
- Ongoing participation to another study.
Key Trial Info
Start Date :
October 15 2013
Trial Type :
INTERVENTIONAL
End Date :
October 31 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01872442
Start Date
October 15 2013
End Date
October 31 2018
Last Update
February 10 2020
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