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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 is currently recruiting participants.
Verified by University Hospital, Bordeaux, December 2008
First Received: December 27, 2007   Last Updated: December 17, 2008   History of Changes
Sponsored by: University Hospital, Bordeaux
Information provided by: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00590837
  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 III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Lomustine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment: 460
Study Start Date: February 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.
2: No Intervention
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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590837

Contacts
Contact: Arnaud Pigneux, MD, PhD 00 33 5 57 65 65 11 arnaud.pigneux@chu-bordeaux.fr

Locations
France
Service des maladies du sang - Hôpital Haut-Lévêque Recruiting
Bordeaux - Pessac, France, 33604
Contact: Arnaud Pigneux, MD, PhD     00 33 5 57 65 65 11     arnaud.pigneux@chu-bordeaux.fr    
Principal Investigator: Arnaud Pigneux, MD, PhD            
Sub-Investigator: Noel Milpied            
Sub-Investigator: Marie-Sarah Dilhuydy            
Sub-Investigator: Carine Foucaud            
Sub-Investigator: Thibaut Leguay            
Sub-Investigator: Krimo Bouabdallah            
Sub-Investigator: Stéphane Vigouroux            
Sub-Investigator: Réza Tabrizi            
Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens Recruiting
Amiens, France, 80054
Principal Investigator: Jean-Pierre MAROLLEAU            
Sub-Investigator: Iona VAIDA            
Sub-Investigator: Bruno ROYER            
Sub-Investigator: Gandhi DAMAJ            
Service Hématologie, Centre Hospitalier Annecy Recruiting
Annecy, France, 74011
Principal Investigator: Frédérique ORSINI-PIOCELLE            
Sub-Investigator: Claire REYNES            
Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon Recruiting
Avignon, France, 84000
Principal Investigator: Gérard LEPEU            
Sub-Investigator: Hacène ZERAZHI            
Service des maladies du sang, Centre Hospitalier Universitaire d'Angers Recruiting
Angers, France, 49033
Principal Investigator: Norbert IFRAH            
Sub-Investigator: Mathilde HUNAULT-BERGER            
Sub-Investigator: Marie-Pierre MOLES            
Sub-Investigator: Sylvie FRANCOIS            
Sub-Investigator: Philippe GUARDIOLA            
Sub-Investigator: Mamoun DIB            
Sub-Investigator: Charles FOUSSARD            
Sub-Investigator: Malgorzata TRUCHAN-GRACZYK            
Sub-Investigator: Françoise BOYER-PERRARD            
Sub-Investigator: Martine GARDEMBAS-PAIN            
Service Hématologie, Centre Hospitalier de la Côte Basque Recruiting
Bayonne, France, 64109
Principal Investigator: Anne BANOS            
Sub-Investigator: Frédéric BAUDUER            
Sub-Investigator: Carla ARAUJO            
Service Hématologie, Hôpital Minjoz Not yet recruiting
Besançon, France, 25030
Principal Investigator: Eric DECONINCK            
Sub-Investigator: Fabrice LAROSA            
Sub-Investigator: Faezeh LEGRAND            
Unité Hématologie, Centre Hospitalier Blois Recruiting
Blois, France, 41016
Principal Investigator: Philippe RODON            
Service Hématologie, Hôpital Dr Duchenne Recruiting
Boulogne-sur-Mer, France, 62321
Principal Investigator: Bachra CHOUFI            
Service Hématologie, Hôpital Augustin Morvan Recruiting
Brest, France, 29609
Principal Investigator: Christian BERTHOU            
Sub-Investigator: Jean-Christophe IANOTTO            
Sub-Investigator: Adrian TEMPESCUL            
Sub-Investigator: Gaëlle GUILLERM            
Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Principal Investigator: Olivier TOURNILHAC            
Sub-Investigator: Jacques-Olivier BAY            
Sub-Investigator: Carine CHALETEIX            
Sub-Investigator: Benoit de RENZIS            
Sub-Investigator: Eric HERMET            
Sub-Investigator: Cécile MOLUCHON-CHABROT            
Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar Not yet recruiting
Colmar, France, 68024
Principal Investigator: Bruno AUDHUY            
Sub-Investigator: Jean-Claude BARATS            
Sub-Investigator: Mirela CHIRILA            
Sub-Investigator: Frédéric KOSHER            
Service Hématologie Clinique, CHU Dijon Hôpital des enfants Recruiting
Dijon, France, 21079
Principal Investigator: Denis CAILLOT            
Sub-Investigator: Olivier CASASNOVAS            
Sub-Investigator: Jean-Noël BASTIE            
Sub-Investigator: Emmanuelle FERRANT            
Sub-Investigator: Ingrid LAFON            
Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble Recruiting
Grenoble, France, 38043
Principal Investigator: Jean Yves CAHN            
Sub-Investigator: Claude-Eric BULABOIS            
Sub-Investigator: Stéphane COURBY            
Sub-Investigator: Frédéric GARBAN            
Sub-Investigator: Rémy GRESSIN            
Sub-Investigator: Lysiane MOLINA            
Sub-Investigator: Brigitte PEGOURIE-BANDELIER            
Sub-Investigator: Marian Heczko            
Service Onco-Hématologie 3, Institut Paoli Calmettes Recruiting
Marseille, France, 13275
Principal Investigator: Norbert VEY            
Sub-Investigator: Thomas PREBET            
Sub-Investigator: Aude CHARBONNIER            
Service Hématologie, Hôpital Purpan Recruiting
Toulouse, France, 31059
Principal Investigator: Michel ATTAL            
Sub-Investigator: Guy LAURENT            
Sub-Investigator: Françoise HUGUET            
Sub-Investigator: Christian RECHER            
Sub-Investigator: Marianne ARQUIER            
Sub-Investigator: Anne HUYNH            
Sub-Investigator: Christiane NOUVEL            
Sub-Investigator: Murielle ROUSSEL            
Sub-Investigator: Willy VAILLANT            
Sub-Investigator: Loïc YSEBAERT            
Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier Recruiting
Montpellier, France, 34295
Principal Investigator: Nathalie FEGUEUX            
Sub-Investigator: Patrice CEBALLOS            
Sub-Investigator: Jean-François ROSSI            
Sub-Investigator: Guillaume CARTRON            
Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse Recruiting
Mulhouse, France, 68070
Principal Investigator: Mario OJEDA URIBE            
Service Hématologie - Médecine Interne, Hôpitaux de Brabois Recruiting
Vandoeuvre-les-Nancy, France, 54511
Principal Investigator: Francis WITZ            
Sub-Investigator: Brigitte WITZ            
Sub-Investigator: Pierre FEUGIER            
Service Hématologie Clinique, CHU -Hôtel Dieu Recruiting
Nantes, France, 44093
Principal Investigator: Jean-Luc HAROUSSEAU            
Sub-Investigator: Jacques DELAUNAY            
Sub-Investigator: Patrice CHEVALLIER            
Sub-Investigator: Thierry GUILLAUME            
Sub-Investigator: Mohamad MOHTY            
Service Hématologie Clinique, Hôpital Archet 1 Not yet recruiting
Nice, France, 06202
Principal Investigator: Lionel MANNONE            
Sub-Investigator: Laurence LEGROS            
Sub-Investigator: Anne SIRVENT            
Service Médecine B - Unité Onco-hématologique, CHU Caremeau Recruiting
Nîmes, France, 30029
Principal Investigator: Eric JOURDAN            
Sub-Investigator: Bruno RICHARD            
Service Oncologie Médicale, Hôpital de la Source Recruiting
Orléans, France, 45067
Principal Investigator: Magda ALEXIS-VIGIER            
Sub-Investigator: Jean-Michel BOULET            
Sub-Investigator: Michèle SCHOENWALD            
Unité d'Hématologie, Hôpital Cochin Recruiting
Paris, France, 75679
Principal Investigator: François DREYFUS            
Sub-Investigator: Didier BOUSCARY            
Service Hématologie, CHG Saint Jean Recruiting
Perpignan, France, 66000
Principal Investigator: Laurence SANHES            
Sub-Investigator: Xavier VALLANTIN            
Sub-Investigator: Jean-Marie CAVO            
Service Hématologie Clinique, Hôpital Robert Debre Recruiting
Reims, France, 51092
Principal Investigator: Chantal HIMBERLIN            
Sub-Investigator: Anne - Marie BLAISE            
Sub-Investigator: Brigitte KOLB            
Sub-Investigator: Alain DELMER            
Service Hématologie Clinique, Hôpital Pontchaillou Recruiting
Rennes, France, 35033
Principal Investigator: Thierry LAMY            
Sub-Investigator: Charles Dauriac            
Sub-Investigator: Martine Escoffre-Barbe            
Sub-Investigator: Marc Bernard            
Sub-Investigator: Sophie De Guibert            
Service d'Hématologie, Institut de Cancérologhie de la Loire Recruiting
Saint Priez en Jarez, France, 42270
Principal Investigator: Emmanuelle TAVERNIER            
Sub-Investigator: Denis GUYOTAT            
Sub-Investigator: Christiane MOUNIER            
Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre Recruiting
Strasbourg, France, 67098
Principal Investigator: Bruno LIOURE            
Sub-Investigator: Raoul HERBRECHT            
Sub-Investigator: Karin BILGER            
Sub-Investigator: Cécile FOHRER            
Service Hématologie Clinique, Hôpital Bretonneau Recruiting
Tours, France, 37044
Principal Investigator: Lotfi BENBOUBKER            
Sub-Investigator: Caroline DARTIGEAS            
Service Hématologie Oncologie, CHR Metz-Thionville Recruiting
Metz, France, 57038
Principal Investigator: Véronique DORVAUX            
Sub-Investigator: Bernard CHRISTIAN            
Sub-Investigator: Sorin VISANICA            
Sub-Investigator: Isabelle GUIBAUD            
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Arnaud Pigneux, MD, PhD University Hospital Bordeaux, France
  More Information

Publications:
Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, Anderson JE, Petersdorf SH. Age and acute myeloid leukemia. Blood. 2006 May 1;107(9):3481-5. Epub 2006 Feb 2.
Sekeres MA, Stone R. Older adults with acute myeloid leukemia. Curr Oncol Rep. 2002 Sep;4(5):403-9. Review.
Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, McIntyre OR, Frei E 3rd. Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B. N Engl J Med. 1994 Oct 6;331(14):896-903.
Stone RM, Berg DT, George SL, Dodge RK, Paciucci PA, Schulman P, Lee EJ, Moore JO, Powell BL, Schiffer CA. Granulocyte-macrophage colony-stimulating factor after initial chemotherapy for elderly patients with primary acute myelogenous leukemia. Cancer and Leukemia Group B. N Engl J Med. 1995 Jun 22;332(25):1671-7.
Witz F, Sadoun A, Perrin MC, Berthou C, Brière J, Cahn JY, Lioure B, Witz B, François S, Desablens B, Pignon B, Le Prisé PY, Audhuy B, Caillot D, Casassus P, Delain M, Christian B, Tellier Z, Polin V, Hurteloup P, Harousseau JL. A placebo-controlled study of recombinant human granulocyte-macrophage colony-stimulating factor administered during and after induction treatment for de novo acute myelogenous leukemia in elderly patients. Groupe Ouest Est Leucémies Aiguës Myéloblastiques (GOELAM). Blood. 1998 Apr 15;91(8):2722-30.
Pigneux A, Perreau V, Jourdan E, Vey N, Dastugue N, Huguet F, Sotto JJ, Salmi LR, Ifrah N, Reiffers J. Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results. Haematologica. 2007 Oct;92(10):1327-34.
Takagi K. [Neurophysiological and clinical aspects of autonomic centers: introduction] Nippon Seirigaku Zasshi. 1972 May;34(5):257-61. Japanese. No abstract available.
Gardin C, Turlure P, Fagot T, Thomas X, Terre C, Contentin N, Raffoux E, de Botton S, Pautas C, Reman O, Bourhis JH, Fenaux P, Castaigne S, Michallet M, Preudhomme C, de Revel T, Bordessoule D, Dombret H. Postremission treatment of elderly patients with acute myeloid leukemia in first complete remission after intensive induction chemotherapy: results of the multicenter randomized Acute Leukemia French Association (ALFA) 9803 trial. Blood. 2007 Jun 15;109(12):5129-35. Epub 2007 Mar 6.
Hegenbart U, Niederwieser D, Sandmaier BM, Maris MB, Shizuru JA, Greinix H, Cordonnier C, Rio B, Gratwohl A, Lange T, Al-Ali H, Storer B, Maloney D, McSweeney P, Chauncey T, Agura E, Bruno B, Maziarz RT, Petersen F, Storb R. Treatment for acute myelogenous leukemia by low-dose, total-body, irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors. J Clin Oncol. 2006 Jan 20;24(3):444-53. Epub 2005 Dec 12.

Responsible Party: University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers: CHUBX 2007/13
Study First Received: December 27, 2007
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00590837     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Leukemia
Idarubicin
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Lomustine
 Antineoplastic Agents, Alkylating
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Alkylating Agents
Cytarabine

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

ClinicalTrials.gov processed this record on May 07, 2009



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