Overview
Liposomal Anthracyclin in the Treatment of Elderly ALL
Status:
Completed
Completed
Trial end date:
2006-10-01
2006-10-01
Target enrollment:
0
0
Participant gender:
All
All
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 dexamethasonePhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
French Innovative Leukemia OrganisationTreatments:
Doxorubicin
Liposomal doxorubicin
Criteria
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