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Completed

NCT Number: NCT00600977

Liposomal Anthracyclin in the Treatment of Elderly ALL

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxorubicine

Drug

9mg/m² J1 J4 2 COURSES

Doxorubicine pegylated

Drug

40 MG/M² J1 2 courses

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2006
First posted
Jan 25, 2008
Registry last updated
Jun 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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