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Liposomal Anthracyclin in the Treatment of Elderly ALL

NCT ID: NCT00600977

Last Updated: 2008-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2006-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Acute Lymphoblastic Leukemia

Keywords

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ALL Chemotherapy Pharmacokinetics of doxorubicin (pegylated or not) elderly ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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doxorubicine

VAD

Group Type ACTIVE_COMPARATOR

Doxorubicine

Intervention Type DRUG

9mg/m² J1 J4 2 COURSES

Doxorubicine pegylated

Doxorubicine pegylated 40 MG/M² J1

Group Type EXPERIMENTAL

Doxorubicine pegylated

Intervention Type DRUG

40 MG/M² J1 2 courses

Interventions

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Doxorubicine

9mg/m² J1 J4 2 COURSES

Intervention Type DRUG

Doxorubicine pegylated

40 MG/M² J1 2 courses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Innovative Leukemia Organisation

OTHER

Sponsor Role lead

Principal Investigators

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Mathilde HUNAULT BERGER, RN

Role: PRINCIPAL_INVESTIGATOR

French Innovative Leukemia Organisation

Locations

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Regional university hospital

Angers, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 20971822 (View on PubMed)

Other Identifiers

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U01-AA1234-01

Identifier Type: -

Identifier Source: secondary_id

GOELAL LALA SA1

Identifier Type: -

Identifier Source: org_study_id