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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00600977 |
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Date of registration:
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26/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Liposomal Anthracyclin in the Treatment of Elderly ALL
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Scientific title:
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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 |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00600977 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Mathilde HUNAULT BERGER, RN |
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Address:
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Telephone:
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Email:
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Affiliation:
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Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 55 years of age and older
- ECOG performance /=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
Age minimum:
55 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Lymphoblastic Leukemia
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Intervention(s)
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Drug: Doxorubicine
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Drug: Doxorubicine pegylated
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Hematological and cutaneous adverse evnts of both types of chemotherapy
[Time Frame: 113 days]
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Complete response rates
[Time Frame: 113 days]
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Economical study
[Time Frame: 113 days]
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Disease free and overall survival
[Time Frame: 4 months]
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Resistance to chemotherapy
[Time Frame: 113 days]
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Secondary ID(s)
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U01-AA1234-01
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GOELAL LALA SA1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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