Liposomal Anthracyclin in the Treatment of Elderly ALL - Full Text View

Purpose

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	Intervention	Phase
Acute Lymphoblastic Leukemia	Drug: Doxorubicine Drug: Doxorubicine pegylated	Phase II

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for:

Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

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

Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

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 ]

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 ]

Enrollment:	60
Study Start Date:	March 2002
Study Completion Date:	October 2006

Arms	Assigned Interventions
doxorubicine: Active Comparator VAD	Drug: Doxorubicine 9mg/m² J1 J4 2 COURSES
Doxorubicine pegylated: Experimental Doxorubicine pegylated 40 MG/M² J1	Drug: Doxorubicine pegylated 40 MG/M² J1 2 courses

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.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600977

Locations


France
	Regional university hospital
	ANGERS, France, 49000

Sponsors and Collaborators

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

Investigators


Principal Investigator:	Mathilde HUNAULT BERGER, RN	Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	GOELAL LALA SA1, U01-AA1234-01
First Received:	September 26, 2007
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00600977
Health Authority:	France: Afssaps - French Health Products Safety Agency; United States: Institutional Review Board

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

ALL

Chemotherapy

Pharmacokinetics of doxorubicin (pegylated or not)

elderly ALL

Study placed in the following topic categories:

Lymphatic Diseases

Leukemia

Leukemia, Lymphoid

Immunoproliferative Disorders

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Lymphoproliferative Disorders

Lymphoma

Doxorubicin

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Antibiotics, Antineoplastic

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	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
ClinicalTrials.gov Identifier:	NCT00600977