Liposomal Anthracyclin in the Treatment of Elderly ALL

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600977
• Other study ID #: GOELAL LALA SA1
• Secondary ID: U01-AA1234-01
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2007
• Last updated: June 25, 2008
• Start date: March 2002
• Est. completion date: October 2006

Study information

• Verified date: June 2008
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Doxorubicine
9mg/m² J1 J4 2 COURSES
• Doxorubicine pegylated
40 MG/M² J1 2 courses

Locations

Country	Name	City	State
France	Regional university hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy		113 days	Yes
Secondary	Hematological and cutaneous adverse evnts of both types of chemotherapy		113 days	Yes
Secondary	Resistance to chemotherapy		113 days	Yes
Secondary	Complete response rates		113 days	Yes
Secondary	Disease free and overall survival		4 months	Yes
Secondary	Economical study		113 days	Yes