Acute Lymphoblastic Leukemia
Conditions
Keywords
ALL, Chemotherapy, Pharmacokinetics of doxorubicin (pegylated or not), elderly ALL
Brief summary
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
Detailed description
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.
Interventions
DRUGDoxorubicine
9mg/m² J1 J4 2 COURSES
DRUGDoxorubicine pegylated
40 MG/M² J1 2 courses
Sponsors
French Innovative Leukemia Organisation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 55 years of age and older * ECOG performance \</=2 or \>/=3 * VIH negative * Absence of previous ALL treatment * Informed consent signed * SGPT and Bilirubin \< 4x upper limit of normal * Normal creatinine for age * cardiac state compatible with anthacyclin
Exclusion criteria
* ALL with Philadelphia Chromosome * ALL3 * CML blasts crisis * Cardiac insufficiency and/ or left ventricular ejection fraction \< 50% * Evolutive infection * Presence of other evolutifs cancer or ongoing treatment * mental status incompatible with inform consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy | 113 days |
Secondary
| Measure | Time frame |
|---|---|
| Hematological and cutaneous adverse evnts of both types of chemotherapy | 113 days |
| Resistance to chemotherapy | 113 days |
| Complete response rates | 113 days |
| Disease free and overall survival | 4 months |
| Economical study | 113 days |
Countries
France
Outcome results
None listed