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Sponsored by: |
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
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Information provided by: | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
ClinicalTrials.gov Identifier: | NCT00600977 |
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
Condition | Intervention | Phase |
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Acute Lymphoblastic Leukemia |
Drug: Doxorubicine Drug: Doxorubicine pegylated |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
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 |
Enrollment: | 60 |
Study Start Date: | March 2002 |
Study Completion Date: | October 2006 |
Arms | Assigned Interventions |
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doxorubicine: Active Comparator
VAD
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Drug: Doxorubicine
9mg/m² J1 J4 2 COURSES
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Doxorubicine pegylated: Experimental
Doxorubicine pegylated 40 MG/M² J1
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Drug: Doxorubicine pegylated
40 MG/M² J1 2 courses
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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.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Presence of other evolutifs cancer or ongoing treatment
France | |
Regional university hospital | |
ANGERS, France, 49000 |
Principal Investigator: | Mathilde HUNAULT BERGER, RN | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
Study ID Numbers: | GOELAL LALA SA1, U01-AA1234-01 |
Study First Received: | September 26, 2007 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00600977 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; United States: Institutional Review Board |
ALL Chemotherapy Pharmacokinetics of doxorubicin (pegylated or not) elderly ALL |
Anti-Bacterial Agents Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoproliferative Disorders Lymphoma Doxorubicin Acute Lymphoblastic Leukemia |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Antibiotics, Antineoplastic |
Pharmacologic Actions Doxorubicin Leukemia Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders |