Clinical trial NCT00590837: Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old
Official title: Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction and Post-remission Chemotherapy in Older Patients With Acute Myeloid Leukaemia, and Feasibility of Allogeneic Transplantation for Patients From 60 to 65 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: AML
Chemotherapy
older
De novo AML
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 459
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall Survival
timeFrame: 1 year
Secondary outcomes:
measure: Complete remission
timeFrame: 1 year
measure: Event-free survival
timeFrame: 1 year
measure: Prognostic factors
timeFrame: 1 year
measure: Quality of Life (QOL)
timeFrame: 1 year
Other outcomes:
Locations:
city: Amiens
country: France
facility: Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens
city: Angers
country: France
facility: Service des maladies du sang, Centre Hospitalier Universitaire d'Angers
city: Annecy
country: France
facility: Service Hématologie, Centre Hospitalier Annecy
city: Argenteuil
country: France
facility: C.H Victor Dupouy
city: Avignon
country: France
facility: Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon
city: Bayonne
country: France
facility: Service Hématologie, Centre Hospitalier de la Côte Basque
city: Besançon
country: France
facility: Service Hématologie, Hôpital Minjoz
city: Blois
country: France
facility: Unité Hématologie, Centre Hospitalier Blois
city: Bordeaux - Pessac
country: France
facility: Service des maladies du sang - Hôpital Haut-Lévêque
city: Boulogne-sur-Mer
country: France
facility: Service Hématologie, Hôpital Dr Duchenne
city: Brest
country: France
facility: Service Hématologie, Hôpital Augustin Morvan
city: Clermont-Ferrand
country: France
facility: Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand
city: Colmar
country: France
facility: Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar
city: Dijon
country: France
facility: Service Hématologie Clinique, CHU Dijon Hôpital des enfants
city: Grenoble
country: France
facility: Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble
city: Marseille
country: France
facility: Service Onco-Hématologie 3, Institut Paoli Calmettes
city: Metz
country: France
facility: Service Hématologie Oncologie, CHR Metz-Thionville
city: Montpellier
country: France
facility: Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier
city: Mulhouse
country: France
facility: Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse
city: Nantes
country: France
facility: Service Hématologie Clinique, CHU -Hôtel Dieu
city: Nice
country: France
facility: Service Hématologie Clinique, Hôpital Archet 1
city: Nîmes
country: France
facility: Service Médecine B - Unité Onco-hématologique, CHU Caremeau
city: Orléans
country: France
facility: Service Oncologie Médicale, Hôpital de la Source
city: Paris
country: France
facility: Unité d'Hématologie, Hôpital Cochin
city: Perpignan
country: France
facility: Service Hématologie, CHG Saint Jean
city: Reims
country: France
facility: Service Hématologie Clinique, Hôpital Robert Debre
city: Rennes
country: France
facility: Service Hématologie Clinique, Hôpital Pontchaillou
city: Saint Priez en Jarez
country: France
facility: Service d'Hématologie, Institut de Cancérologhie de la Loire
city: Strasbourg
country: France
facility: Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre
city: Toulouse
country: France
facility: Service Hématologie, Hôpital Purpan
city: Tours
country: France
facility: Service Hématologie Clinique, Hôpital Bretonneau
city: Vandoeuvre-les-Nancy
country: France
facility: Service Hématologie - Médecine Interne, Hôpitaux de Brabois
Study officials:
affiliation: University Hospital Bordeaux, France
name: Arnaud Pigneux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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