Liposomal Anthracyclin in the Treatment of Elderly ALL
Primary Purpose
Acute Lymphoblastic Leukemia
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Doxorubicine
Doxorubicine pegylated
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring ALL, Chemotherapy, Pharmacokinetics of doxorubicin (pegylated or not), elderly ALL
Eligibility 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
Sites / Locations
- Regional university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
doxorubicine
Doxorubicine pegylated
Arm Description
VAD
Doxorubicine pegylated 40 MG/M² J1
Outcomes
Primary Outcome Measures
Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy
Secondary Outcome Measures
Hematological and cutaneous adverse evnts of both types of chemotherapy
Resistance to chemotherapy
Complete response rates
Disease free and overall survival
Economical study
Full Information
NCT ID
NCT00600977
First Posted
September 26, 2007
Last Updated
June 25, 2008
Sponsor
French Innovative Leukemia Organisation
1. Study Identification
Unique Protocol Identification Number
NCT00600977
Brief Title
Liposomal Anthracyclin in the Treatment of Elderly ALL
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 Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
French Innovative Leukemia Organisation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
ALL, Chemotherapy, Pharmacokinetics of doxorubicin (pegylated or not), elderly ALL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
doxorubicine
Arm Type
Active Comparator
Arm Description
VAD
Arm Title
Doxorubicine pegylated
Arm Type
Experimental
Arm Description
Doxorubicine pegylated 40 MG/M² J1
Intervention Type
Drug
Intervention Name(s)
Doxorubicine
Intervention Description
9mg/m² J1 J4 2 COURSES
Intervention Type
Drug
Intervention Name(s)
Doxorubicine pegylated
Intervention Description
40 MG/M² J1 2 courses
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Hematological and cutaneous adverse evnts of both types of chemotherapy
Time Frame
113 days
Title
Resistance to chemotherapy
Time Frame
113 days
Title
Complete response rates
Time Frame
113 days
Title
Disease free and overall survival
Time Frame
4 months
Title
Economical study
Time Frame
113 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathilde HUNAULT BERGER, RN
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional university hospital
City
Angers
ZIP/Postal Code
49000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
20971822
Citation
Hunault-Berger M, Leguay T, Thomas X, Legrand O, Huguet F, Bonmati C, Escoffre-Barbe M, Legros L, Turlure P, Chevallier P, Larosa F, Garban F, Reman O, Rousselot P, Dhedin N, Delannoy A, Lafage-Pochitaloff M, Bene MC, Ifrah N, Dombret H; Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL). A randomized study of pegylated liposomal doxorubicin versus continuous-infusion doxorubicin in elderly patients with acute lymphoblastic leukemia: the GRAALL-SA1 study. Haematologica. 2011 Feb;96(2):245-52. doi: 10.3324/haematol.2010.027862. Epub 2010 Oct 22.
Results Reference
derived
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Liposomal Anthracyclin in the Treatment of Elderly ALL
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