Overview

Liposomal Anthracyclin in the Treatment of Elderly ALL

Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
0
Participant gender:
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 dexamethasone
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
French Innovative Leukemia Organisation
Treatments:
Doxorubicin
Liposomal doxorubicin
Criteria
Inclusion Criteria:

- 55 years of age and older

- ECOG performance /=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