Liposomal Anthracyclin in the Treatment of Elderly ALL

Sponsor

French Innovative Leukemia Organisation (Other)

Overall Status

Completed

CT.gov ID

NCT00600977

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: Doxorubicine Drug: Doxorubicine pegylated	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2002

Actual Study Completion Date :

Oct 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: doxorubicine VAD	Drug: Doxorubicine 9mg/m² J1 J4 2 COURSES
Experimental: Doxorubicine pegylated Doxorubicine pegylated 40 MG/M² J1	Drug: Doxorubicine pegylated 40 MG/M² J1 2 courses

Arm

Intervention/Treatment

Active Comparator: doxorubicine

VAD

Drug: Doxorubicine

9mg/m² J1 J4 2 COURSES

Experimental: Doxorubicine pegylated

Doxorubicine pegylated 40 MG/M² J1

Drug: Doxorubicine pegylated

40 MG/M² J1 2 courses

Outcome Measures

Primary Outcome Measures

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

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]