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
2 other identifiers
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2002
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 25, 2008
CompletedJune 26, 2008
June 1, 2008
September 26, 2007
June 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy
113 days
Secondary Outcomes (5)
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
Study Arms (2)
doxorubicine
ACTIVE COMPARATORVAD
Doxorubicine pegylated
EXPERIMENTALDoxorubicine pegylated 40 MG/M² J1
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Regional university hospital
Angers, 49000, France
Related Publications (1)
Hunault-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: 20971822DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathilde HUNAULT BERGER, RN
French Innovative Leukemia Organisation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 26, 2007
First Posted
January 25, 2008
Study Start
March 1, 2002
Study Completion
October 1, 2006
Last Updated
June 26, 2008
Record last verified: 2008-06