Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old
NCT ID: NCT00590837
Last Updated: 2014-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
459 participants
INTERVENTIONAL
2008-02-29
2013-12-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Patients will be treated by adding lomustine to chemotherapy
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
Patients will be treated without adding lomustine to chemotherapy
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients with no unfavourable cytogenetic (based on GOELAMS-BGMT criteria)
* Performance status and Sorror score \< 3 .
* Signed and dated informed consent.
Exclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Arnaud Pigneux, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Locations
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Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens
Amiens, , France
Service des maladies du sang, Centre Hospitalier Universitaire d'Angers
Angers, , France
Service Hématologie, Centre Hospitalier Annecy
Annecy, , France
C.H Victor Dupouy
Argenteuil, , France
Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon
Avignon, , France
Service Hématologie, Centre Hospitalier de la Côte Basque
Bayonne, , France
Service Hématologie, Hôpital Minjoz
Besançon, , France
Unité Hématologie, Centre Hospitalier Blois
Blois, , France
Service des maladies du sang - Hôpital Haut-Lévêque
Bordeaux - Pessac, , France
Service Hématologie, Hôpital Dr Duchenne
Boulogne-sur-Mer, , France
Service Hématologie, Hôpital Augustin Morvan
Brest, , France
Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand
Clermont-Ferrand, , France
Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar
Colmar, , France
Service Hématologie Clinique, CHU Dijon Hôpital des enfants
Dijon, , France
Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble
Grenoble, , 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
Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse
Mulhouse, , France
Service Hématologie Clinique, CHU -Hôtel Dieu
Nantes, , 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
Unité d'Hématologie, Hôpital Cochin
Paris, , France
Service Hématologie, CHG Saint Jean
Perpignan, , France
Service Hématologie Clinique, Hôpital Robert Debre
Reims, , France
Service Hématologie Clinique, Hôpital Pontchaillou
Rennes, , 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, Hôpital Purpan
Toulouse, , France
Service Hématologie Clinique, Hôpital Bretonneau
Tours, , France
Service Hématologie - Médecine Interne, Hôpitaux de Brabois
Vandœuvre-lès-Nancy, , France
Countries
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References
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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. doi: 10.1182/blood-2005-09-3724. Epub 2006 Feb 2.
Sekeres MA, Stone R. Older adults with acute myeloid leukemia. Curr Oncol Rep. 2002 Sep;4(5):403-9. doi: 10.1007/s11912-002-0034-y.
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. doi: 10.1056/NEJM199410063311402.
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. doi: 10.1056/NEJM199506223322503.
Witz F, Sadoun A, Perrin MC, Berthou C, Briere J, Cahn JY, Lioure B, Witz B, Francois S, Desablens B, Pignon B, Le Prise 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 Leucemies Aigues Myeloblastiques (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. doi: 10.3324/haematol.11068.
Takagi K. [Neurophysiological and clinical aspects of autonomic centers: introduction]. Nihon Seirigaku Zasshi. 1972 May;34(5):257-61. No abstract available. Japanese.
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. doi: 10.1182/blood-2007-02-069666. 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. doi: 10.1200/JCO.2005.03.1765. Epub 2005 Dec 12.
Largeaud L, Cornillet-Lefebvre P, Hamel JF, Dumas PY, Prade N, Dufrechou S, Plenecassagnes J, Luquet I, Blanchet O, Banos A, Bene MC, Bernard M, Bertoli S, Bonmati C, Fornecker LM, Guieze R, Haddaoui L, Hunault M, Ianotto JC, Jourdan E, Ojeda M, Peterlin P, Vey N, Zerazhi H, Yosr H, Mineur A, Cahn JY, Ifrah N, Recher C, Pigneux A, Delabesse E; French Innovative Leukemia Organization (FILO). Lomustine is beneficial to older AML with ELN2017 adverse risk profile and intermediate karyotype: a FILO study. Leukemia. 2021 May;35(5):1291-1300. doi: 10.1038/s41375-020-01031-1. Epub 2020 Sep 18.
Other Identifiers
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CHUBX 2007/13
Identifier Type: -
Identifier Source: org_study_id
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