Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Multicentric Phase II-III Randomized Study Safety of Intraveinous Liposomal Pegylated Doxorubicin Versus Continuous Infusion of Doxorubicin During Induction Treatment of Acute Lymphoblastic Leukemia in Patients
Phase II multicentric study comparing VAD regimen with continuous infusion over 96 hours of doxorubicin, vincristine and dexamethasone to a 90 minutes infusion of equivalent doses of Dox li-PEG, bolus infusion of vincristine and dexamethasone
Patients aged 55 years or over will be assessed for response to steroids from day -7 to day
0 During steroid therapy, Ph status will be determinated : patients with Ph+ ve ALL will be
treated according to the another French Protocol while patients with Ph-ve ALL will be
included in the "caelyx" protocol and randomly allocated to induction with VAD or with
vadox-li-Peg (caelyx).
A second course of induction therapy with VAD+ cyclophosphamide of Vadox-li-peg+
cyclophosphamide(according to the initial randomization arm) will then be given to all
patients.
Consolidation therapy included 2 courses of vad or of vadox-li-Peg , according to the
initial random allocation, followed by two courses of cytarabine,cyclophosphamide and
thioguanine.
During induction and consolidation therapy, doxorubicin and liposomal pegylated doxorubicin
pharmacokinetics will be assessed in all patients.
Treatment of occult CNS invasion includes skull radiotherapy and 6 intrathecal
injections(steroÏds+methotrexate) A two years maintenance course with 6 mercaptopurine and
methotrexate will then be offered to all patients.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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