Liposomal Anthracyclin in the Treatment of Elderly ALL

Phase 2

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: Doxorubicine pegylated; Drug: Doxorubicine

• Registration Number: NCT00600977
• Lead Sponsor: French Innovative Leukemia Organisation

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

Detailed Description

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.

Study Timeline

• Study Start: 2002-03
• Study Completion: 2006-10
• Study First Submitted: 2007-09-26
• Study First Submitted QC: 2008-01-24
• Study First Posted: 2008-01-25
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-25
• Last Update Posted: 2008-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doxorubicine pegylated	Doxorubicine pegylated	Doxorubicine pegylated 40 MG/M² J1
doxorubicine	Doxorubicine	VAD

Primary Outcome Measures

Name	Time	Method
Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy	113 days

Secondary Outcome Measures

Name	Time	Method
Hematological and cutaneous adverse evnts of both types of chemotherapy	113 days
Resistance to chemotherapy	113 days
Complete response rates	113 days
Economical study	113 days
Disease free and overall survival	4 months

Trial Locations

Locations (1)

Regional university hospital; 🇫🇷 Angers, France