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Liposomal Anthracyclin in the Treatment of Elderly ALL
This study has been completed.
First Received: September 26, 2007   Last Updated: June 25, 2008   History of Changes
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
  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 Myocet
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

Additional Information:
No publications provided

Study ID Numbers: GOELAL LALA SA1, U01-AA1234-01
Study First Received: September 26, 2007
Last Updated: June 25, 2008
ClinicalTrials.gov Identifier: NCT00600977     History of Changes
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:
Anti-Bacterial Agents
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Lymphoma
Doxorubicin
Acute Lymphoblastic Leukemia

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

ClinicalTrials.gov processed this record on May 06, 2009