Liposomal Anthracyclin in the Treatment of Elderly ALL - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 26, 2007

Last Updated Date

June 25, 2008

Start Date ^†

March 2002

Current Primary Outcome Measures ^†

Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00600977 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Hematological and cutaneous adverse evnts of both types of chemotherapy [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
Resistance to chemotherapy [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
Complete response rates [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
Disease free and overall survival [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Economical study [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Liposomal Anthracyclin in the Treatment of Elderly ALL

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

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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^†

Acute Lymphoblastic Leukemia

Intervention ^†

Drug: Doxorubicine
Drug: Doxorubicine pegylated

Study Arms / Comparison Groups

Active Comparator: VAD
Experimental: Doxorubicine pegylated 40 MG/M² J1

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00600977

Responsible Party

Secondary IDs ^††

U01-AA1234-01

Study Sponsor ^†

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Collaborators ^††

Investigators ^†

Principal Investigator:

Mathilde HUNAULT BERGER, RN

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Information Provided By

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.