We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

Combination of Dasatinib and Peg-Interferon Alpha 2b in First Line for Chronic Myeloid Leukemia in Chronic Phase

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01872442
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : February 10, 2020
Information provided by (Responsible Party):
Poitiers University Hospital

Tracking Information
First Submitted Date  ICMJE May 14, 2013
First Posted Date  ICMJE June 7, 2013
Last Update Posted Date February 10, 2020
Actual Study Start Date  ICMJE October 15, 2013
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
Cumulative rate of molecular response [ Time Frame: at 12 months. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
  • Rate of complete cytogenetic response [ Time Frame: 3, 6, 12, 18, 24 months, and every 12 months thereafter. ]
  • Rate of major molecular responses [ Time Frame: 3, 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter. ]
  • Rate of molecular response [ Time Frame: 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter. ]
    Rate of molecular response 4.5 and 5.0
  • Kinetics and duration [ Time Frame: 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter ]
    Cumulative rate, Kinetics and duration CCR, MMR, MR4.5, MR5.0
  • Rate of PegIFN-α2b and dasatinib discontinuation [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Combination of Dasatinib and Peg-Interferon Alpha 2b in First Line for Chronic Myeloid Leukemia in Chronic Phase
Official Title  ICMJE Not Provided
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 was demonstrated in the clinical SPIRIT trial. In this study, the investigators address the question of the efficacy and safety of dasatinib in combination with low dose of Peg-IFNα-2b as frontline therapy for patients with newly diagnosed Chronic Myeloid Leukemia in Chronic phase.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Not Provided
Condition  ICMJE Chronic Phase of Chronic Myeloid Leukemia
Intervention  ICMJE
  • Drug: Dasatinib

    Dasatinib 100mg daily starting at inclusion

    If ANC ≤ 1.5.109/L, platelets ≤ 100.0.109/L or lymphocytes > 4.0.109/L at 3 months, dasatinib will be continued alone, and patients will be still followed in the study

  • Drug: Peg-Interferon alpha2b
    30 µg weekly starting month 4- month 21
Study Arms  ICMJE
  • Experimental: Dasatinib
    Dasatinib,Bristol Myers Squibb
    • Drug: Dasatinib
    • Drug: Peg-Interferon alpha2b
  • Experimental: Peg-Interferon alpha2b
    Peg-Interferon alpha2b (Peg-IFN α2b), Merck
    • Drug: Dasatinib
    • Drug: Peg-Interferon alpha2b
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 31, 2018
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 dasatinib.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01872442
Other Study ID Numbers  ICMJE DASA-PegIFN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Poitiers University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Poitiers University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lydia ROY, MD Poitiers University Hospital
PRS Account Poitiers University Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP