Liposomal Anthracyclin in the Treatment of Elderly ALL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00600977
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : June 26, 2008
Information provided by:
French Innovative Leukemia Organisation

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 Type : Interventional  (Clinical Trial)
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 : March 2002
Study Completion Date : October 2006

Arm Intervention/treatment
Active Comparator: doxorubicine
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Hematological and cutaneous adverse evnts of both types of chemotherapy [ Time Frame: 113 days ]
  2. Resistance to chemotherapy [ Time Frame: 113 days ]
  3. Complete response rates [ Time Frame: 113 days ]
  4. Disease free and overall survival [ Time Frame: 4 months ]
  5. Economical study [ Time Frame: 113 days ]

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00600977

Regional university hospital
Angers, France, 49000
Sponsors and Collaborators
French Innovative Leukemia Organisation
Principal Investigator: Mathilde HUNAULT BERGER, RN French Innovative Leukemia Organisation

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00600977     History of Changes
Other Study ID Numbers: GOELAL LALA SA1
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: June 26, 2008
Last Verified: June 2008

Keywords provided by French Innovative Leukemia Organisation:
Pharmacokinetics of doxorubicin (pegylated or not)
elderly ALL

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action