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Liposomal Anthracyclin in the Treatment of Elderly ALL

This study has been completed.
Sponsor:
Information provided by:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT00600977
First received: September 26, 2007
Last updated: June 25, 2008
Last verified: June 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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
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

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00600977     History of Changes
Other Study ID Numbers: GOELAL LALA SA1, U01-AA1234-01
Study First Received: September 26, 2007
Last Updated: June 25, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013