Status and phase
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About
The Primary objective is to assess the non-inferiority of the experimental arm (arm B) compared to the control arm (arm A) in terms of Major Molecular Response (MMolR) after the 4th cycle (MRD4) in patients aged 18-59 years old with de novo Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL)
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Inclusion criteria
Patient
Note 1: Secondary ALL (antecedent of chemo- or radio-therapy) can be included Note 2: In case of high vascular risk (see section "study management") the patient will not be able to receive nilotinib unless an ultra sound Doppler of the neck and lower limbs has been performed during the pre-phase and treatment validated by the medical coordinators of the protocol via the secretariat.
Exclusion criteria
Patient:
Previously treated with Tyrosine Kinase Inhibitor (TKI)
With another active malignancy
With general or visceral contra-indication to intensive therapy (except if considered related to the ALL):
With heart failure, including at least one of the following criteria:
Active uncontrolled infection, any other concurrent disease deemed to interfere with the conduct of the study as judged by the investigator
Severe evolving infection, or known HIV or Human T-Lymphotropic Virus type I (HTLV1) seropositivity, or active infection by hepatitis B or C virus
Pregnant (beta-HCG) or nursing woman
Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least three months thereafter. Patient not willing to ensure not to beget a child during participation in the study and at least three months thereafter.
Having received an investigational treatment or participation in another trial within 30 days prior to entering this study.
Not able to bear with the procedures or the frequency of visits planned in the trial.
Unable to consent, under tutelage or curators, or judiciary safeguard
Primary purpose
Allocation
Interventional model
Masking
265 participants in 2 patient groups
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Central trial contact
Véronique Lhéritier; Hervé Dombret, MDPhD
Data sourced from clinicaltrials.gov
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