Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old (LAM-SA 2007)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00590837
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : April 2, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Lomustine Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: 1
Patients will be treated by adding lomustine to chemotherapy
Drug: Lomustine

Induction: chemotherapy + lomustine (CCNU), 200 mg/m2 orally at day 1.

Consolidation: chemotherapy + lomustine (CCNU), 80 mg orally at day 1.

Reinductions: chemotherapy + lomustine (CCNU), 40 mg orally at day 1.

No Intervention: 2
Patients will be treated without adding lomustine to chemotherapy

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Complete remission [ Time Frame: 1 year ]
  2. Event-free survival [ Time Frame: 1 year ]
  3. Prognostic factors [ Time Frame: 1 year ]
  4. Quality of Life (QOL) [ Time Frame: 1 year ]

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00590837

Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens
Amiens, France, 80054
Service des maladies du sang, Centre Hospitalier Universitaire d'Angers
Angers, France, 49033
Service Hématologie, Centre Hospitalier Annecy
Annecy, France, 74011
C.H Victor Dupouy
Argenteuil, France, 95100
Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon
Avignon, France, 84000
Service Hématologie, Centre Hospitalier de la Côte Basque
Bayonne, France, 64109
Service Hématologie, Hôpital Minjoz
Besançon, France, 25030
Unité Hématologie, Centre Hospitalier Blois
Blois, France, 41016
Service des maladies du sang - Hôpital Haut-Lévêque
Bordeaux - Pessac, France, 33604
Service Hématologie, Hôpital Dr Duchenne
Boulogne-sur-Mer, France, 62321
Service Hématologie, Hôpital Augustin Morvan
Brest, France, 29609
Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000
Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar
Colmar, France, 68024
Service Hématologie Clinique, CHU Dijon Hôpital des enfants
Dijon, France, 21079
Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble
Grenoble, France, 38043
Service Onco-Hématologie 3, Institut Paoli Calmettes
Marseille, France, 13275
Service Hématologie Oncologie, CHR Metz-Thionville
Metz, France, 57038
Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier
Montpellier, France, 34295
Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse
Mulhouse, France, 68070
Service Hématologie Clinique, CHU -Hôtel Dieu
Nantes, France, 44093
Service Hématologie Clinique, Hôpital Archet 1
Nice, France, 06202
Service Médecine B - Unité Onco-hématologique, CHU Caremeau
Nîmes, France, 30029
Service Oncologie Médicale, Hôpital de la Source
Orléans, France, 45067
Unité d'Hématologie, Hôpital Cochin
Paris, France, 75679
Service Hématologie, CHG Saint Jean
Perpignan, France, 66000
Service Hématologie Clinique, Hôpital Robert Debre
Reims, France, 51092
Service Hématologie Clinique, Hôpital Pontchaillou
Rennes, France, 35033
Service d'Hématologie, Institut de Cancérologhie de la Loire
Saint Priez en Jarez, France, 42270
Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre
Strasbourg, France, 67098
Service Hématologie, Hôpital Purpan
Toulouse, France, 31059
Service Hématologie Clinique, Hôpital Bretonneau
Tours, France, 37044
Service Hématologie - Médecine Interne, Hôpitaux de Brabois
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
University Hospital, Bordeaux
Principal Investigator: Arnaud Pigneux, MD, PhD University Hospital Bordeaux, France


Responsible Party: University Hospital, Bordeaux Identifier: NCT00590837     History of Changes
Other Study ID Numbers: CHUBX 2007/13
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014

Keywords provided by University Hospital, Bordeaux:
De novo AML

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents