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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00590837
First received: December 27, 2007
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Drug: Lomustine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complete remission [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Event-free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Prognostic factors [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Quality of Life (QOL) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 459
Study Start Date: February 2008
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590837

Locations
France
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
Investigators
Principal Investigator: Arnaud Pigneux, MD, PhD University Hospital Bordeaux, France
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00590837     History of Changes
Other Study ID Numbers: CHUBX 2007/13
Study First Received: December 27, 2007
Last Updated: April 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
AML
Chemotherapy
older
De novo AML

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

ClinicalTrials.gov processed this record on September 18, 2014