Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
---|---|
Information provided by: | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
ClinicalTrials.gov Identifier: | NCT00480064 |
A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\m2 orally at day 1). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.
Condition | Intervention | Phase |
---|---|---|
Acute Myeloid Leukemia |
Drug: Lomustine, intermediate dose cytarabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction Chemotherapy and Adding Intermediate Dose Cytarabine to Consolidation in Older Patients With Acute Myeloid Leukaemia |
Enrollment: | 360 |
Study Start Date: | July 1995 |
Study Completion Date: | May 2007 |
Induction therapy: Patients were randomized to receive idarubicin plus cytarabine (IC) or the same drugs plus lomustine (ICL), the latter given at the dose of 200 mg/m2 orally at day 1. Patients with persistent leukemia in the bone marrow, defined by at least 20% marrow cellularity with more than 5% blasts on day 14 or at a subsequent time point following initiation of induction therapy, received a second course of induction chemotherapy identical to the initial induction course. Non-responders to the second induction course were taken off the protocol.
Consolidation therapy: After completing induction treatment, patients who were in complete remission after 1 or 2 induction courses received a course of consolidation (IC’) therapy with idarubicin and subcutaneous cytarabine. Subsequently, if stable remission persisted, the patients received maintenance therapy or maintenance therapy preceded by a second consolidation (IIC) with intermediate-dose cytarabine. Randomization was performed as soon as CR was achieved.
Maintenance therapy: This was conducted in all patients with persisting CR one month after completing the first (IC) or second (IIC) consolidation and consisted of the following: five courses of combination chemotherapy at 1, 3, 6, 9 and 13 months from the last consolidation, namely cytarabine (subcutaneously) and idarubicin and between these courses for one year: a continuous regimen of methotrexate and 6-mercaptopurine, as alternating 10 day-courses .
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Josy REIFFERS, MD MS | |
Pessac, France, 33604 |
Principal Investigator: | JOSY REIFFERS, MD | CHU Haut-Leveque Pessac 33604 France |
Study ID Numbers: | BGMT95-V |
Study First Received: | May 29, 2007 |
Last Updated: | May 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00480064 |
Health Authority: | France: Ministry of Health |
AML older patients lomustine |
Leukemia Idarubicin Lomustine Acute myelogenous leukemia |
Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents |