Liposomal Anthracyclin in the Treatment of Elderly ALL

June 25, 2008 updated by: French Innovative Leukemia Organisation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Regional University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
113 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Hematological and cutaneous adverse evnts of both types of chemotherapy
Time Frame: 113 days
113 days
Resistance to chemotherapy
Time Frame: 113 days
113 days
Complete response rates
Time Frame: 113 days
113 days
Disease free and overall survival
Time Frame: 4 months
4 months
Economical study
Time Frame: 113 days
113 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Investigators

  • Principal Investigator: Mathilde HUNAULT BERGER, RN, French Innovative Leukemia Organisation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

January 24, 2008

First Posted (ESTIMATE)

January 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2008

Last Update Submitted That Met QC Criteria

June 25, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOELAL LALA SA1
  • U01-AA1234-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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