Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old
- Registration Number
- NCT00590837
- Lead Sponsor
- University Hospital, Bordeaux
- Brief Summary
A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.
- Detailed Description
* Principal Objective: The primary objective of this study is to assess the ability of lomustine to increase the overall survival by adding lomustine to induction and post-remission chemotherapy.
* Secondary Objectives:
* To assess the ability of lomustine to increase the CR rate.
* To assess the ability of lomustine to increase the event-free survival.
* To evaluate the toxicity and side-effects of lomustine.
* To evaluate the feasibility of reduced conditioning allogeneic transplantation \*between 60 and 65 years old.
* To evaluate prognostic factors.
* To evaluate QOL in elderly.
* Study design: Parallel
* Study plan:
* Induction therapy: Patients will be randomized to receive idarubicin (5d) plus cytarabine or the same drugs plus lomustine, the latter given at the dose of 200 mg/m2 orally at day 1.
* Consolidation therapy: After completing induction treatment, patients who are in complete remission will receive a course of consolidation therapy with idarubicin (3d) and subcutaneous cytarabine.
* Maintenance therapy: In all patients with persisting CR one month after completing consolidation: six courses of monthly combination chemotherapy (idarubicin (1d) and subcutaneous cytarabine) and then a continuous regimen of methotrexate and 6-mercaptopurine, for 6 months.
* Allogeneic transplantation: Patients between 60 and 65 years old with a full matched donor will receive after consolidation (if still in CR) an alloBMT with a reduced conditioning regimen of Fludarabine (3d) and TBI (2Gy).
* Number of subjects: 460
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 459
- Patients aged 60 years and older with de novo AML and non-poor cytogenetic features.
- Patients with no unfavourable cytogenetic (based on GOELAMS-BGMT criteria)
- Performance status and Sorror score < 3 .
- Signed and dated informed consent.
- Acute promyelocytic leukemia.
- Patients with myeloproliferative syndromes prior to diagnosis of AML.
- Patients who previously had myelodysplastic syndrome.
- Positive serology for HIV.
- Patients with unfavourable cytogenetic
- Patients with an isolated medullary extra localization of their disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Lomustine Patients will be treated by adding lomustine to chemotherapy
- Primary Outcome Measures
Name Time Method Overall Survival 1 year
- Secondary Outcome Measures
Name Time Method Complete remission 1 year Event-free survival 1 year Prognostic factors 1 year Quality of Life (QOL) 1 year
Trial Locations
- Locations (32)
Service Hématologie, Hôpital Augustin Morvan
🇫🇷Brest, France
Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens
🇫🇷Amiens, France
Service des maladies du sang, Centre Hospitalier Universitaire d'Angers
🇫🇷Angers, France
Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar
🇫🇷Colmar, France
Service Hématologie Clinique, Hôpital Archet 1
🇫🇷Nice, France
Service Médecine B - Unité Onco-hématologique, CHU Caremeau
🇫🇷Nîmes, France
Service Oncologie Médicale, Hôpital de la Source
🇫🇷Orléans, France
Service Hématologie, CHG Saint Jean
🇫🇷Perpignan, France
C.H Victor Dupouy
🇫🇷Argenteuil, France
Unité Hématologie, Centre Hospitalier Blois
🇫🇷Blois, France
Service Hématologie, Centre Hospitalier Annecy
🇫🇷Annecy, France
Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon
🇫🇷Avignon, France
Service Hématologie, Hôpital Minjoz
🇫🇷Besançon, France
Service des maladies du sang - Hôpital Haut-Lévêque
🇫🇷Bordeaux - Pessac, France
Service Hématologie, Centre Hospitalier de la Côte Basque
🇫🇷Bayonne, France
Service Hématologie, Hôpital Dr Duchenne
🇫🇷Boulogne-sur-Mer, France
Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble
🇫🇷Grenoble, France
Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Service Hématologie Clinique, CHU Dijon Hôpital des enfants
🇫🇷Dijon, France
Service Onco-Hématologie 3, Institut Paoli Calmettes
🇫🇷Marseille, France
Service Hématologie Oncologie, CHR Metz-Thionville
🇫🇷Metz, France
Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier
🇫🇷Montpellier, France
Service Hématologie Clinique, CHU -Hôtel Dieu
🇫🇷Nantes, France
Unité d'Hématologie, Hôpital Cochin
🇫🇷Paris, France
Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse
🇫🇷Mulhouse, France
Service Hématologie Clinique, Hôpital Robert Debre
🇫🇷Reims, France
Service d'Hématologie, Institut de Cancérologhie de la Loire
🇫🇷Saint Priez en Jarez, France
Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre
🇫🇷Strasbourg, France
Service Hématologie Clinique, Hôpital Pontchaillou
🇫🇷Rennes, France
Service Hématologie, Hôpital Purpan
🇫🇷Toulouse, France
Service Hématologie Clinique, Hôpital Bretonneau
🇫🇷Tours, France
Service Hématologie - Médecine Interne, Hôpitaux de Brabois
🇫🇷Vandoeuvre-les-Nancy, France