Liposomal Anthracyclin in the Treatment of Elderly ALL
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
Acute Lymphoblastic Leukemia
Drug: Doxorubicine pegylated
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
- Hematological and cutaneous adverse evnts of both types of chemotherapy [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
- Resistance to chemotherapy [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
- Complete response rates [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
- Disease free and overall survival [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Economical study [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2002|
|Study Completion Date:||October 2006|
Active Comparator: doxorubicine
9mg/m² J1 J4 2 COURSES
Experimental: Doxorubicine pegylated
Doxorubicine pegylated 40 MG/M² J1
Drug: Doxorubicine pegylated
40 MG/M² J1 2 courses
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600977
|Regional university hospital|
|Angers, France, 49000|
|Principal Investigator:||Mathilde HUNAULT BERGER, RN||Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS|