Clinical trial · Interventional
Liposomal Anthracyclin in the Treatment of Elderly ALL
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
NCT00600977CI-TRIAL-00001553completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicine | Drug | Doxorubicin | ALIAS |
| Doxorubicine pegylated | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- doxorubicine
- description
- VAD
- interventionNames
- Drug: Doxorubicine
- type
- EXPERIMENTAL
- label
- Doxorubicine pegylated
- description
- Doxorubicine pegylated 40 MG/M² J1
- interventionNames
- Drug: Doxorubicine pegylated
Primary outcomes (1)
- measure
- Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy
- timeFrame
- 113 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHunault-Berger M, Leguay T, Thomas X, Legrand O, Huguet F, Bonmati C, Escoffre-Barbe M, Legros L, Turlure P, Chevallier P, Larosa F, Garban F, Reman O, Rousselot P, Dhedin N, Delannoy A, Lafage-Pochitaloff M, Bene MC, Ifrah N, Dombret H; Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL). A randomized study of pegylated liposomal doxorubicin versus continuous-infusion doxorubicin in elderly patients with acute lymphoblastic leukemia: the GRAALL-SA1 study. Haematologica. 2011 Feb;96(2):245-52. doi: 10.3324/haematol.2010.027862. Epub 2010 Oct 22. PMID 20971822