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

NCT00590837 | Completed Phase 3 DMC

• 1 other identifier: CHUBX 2007/13
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 32

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.

Conditions

Acute Myeloid Leukemia

Keywords

AML; Chemotherapy; older; De novo AML

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  1 year

Secondary Outcomes (4)

• Complete remission

  1 year

• Event-free survival

  1 year

• Prognostic factors

  1 year

• Quality of Life (QOL)

  1 year

Study Arms (2)

1

EXPERIMENTAL

Patients will be treated by adding lomustine to chemotherapy

Drug: Lomustine

2

NO INTERVENTION

Patients will be treated without adding lomustine to chemotherapy

Interventions

Lomustine DRUG

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.

1

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (32)

Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens

Amiens, 80054, France

Location

Service des maladies du sang, Centre Hospitalier Universitaire d'Angers

Angers, 49033, France

Location

Service Hématologie, Centre Hospitalier Annecy

Annecy, 74011, France

Location

C.H Victor Dupouy

Argenteuil, 95100, France

Location

Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon

Avignon, 84000, France

Location

Service Hématologie, Centre Hospitalier de la Côte Basque

Bayonne, 64109, France

Location

Service Hématologie, Hôpital Minjoz

Besançon, 25030, France

Location

Unité Hématologie, Centre Hospitalier Blois

Blois, 41016, France

Location

Service des maladies du sang - Hôpital Haut-Lévêque

Bordeaux - Pessac, 33604, France

Location

Service Hématologie, Hôpital Dr Duchenne

Boulogne-sur-Mer, 62321, France

Location

Service Hématologie, Hôpital Augustin Morvan

Brest, 29609, France

Location

Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar

Colmar, 68024, France

Location

Service Hématologie Clinique, CHU Dijon Hôpital des enfants

Dijon, 21079, France

Location

Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble

Grenoble, 38043, France

Location

Service Onco-Hématologie 3, Institut Paoli Calmettes

Marseille, 13275, France

Location

Service Hématologie Oncologie, CHR Metz-Thionville

Metz, 57038, France

Location

Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier

Montpellier, 34295, France

Location

Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse

Mulhouse, 68070, France

Location

Service Hématologie Clinique, CHU -Hôtel Dieu

Nantes, 44093, France

Location

Service Hématologie Clinique, Hôpital Archet 1

Nice, 06202, France

Location

Service Médecine B - Unité Onco-hématologique, CHU Caremeau

Nîmes, 30029, France

Location

Service Oncologie Médicale, Hôpital de la Source

Orléans, 45067, France

Location

Unité d'Hématologie, Hôpital Cochin

Paris, 75679, France

Location

Service Hématologie, CHG Saint Jean

Perpignan, 66000, France

Location

Service Hématologie Clinique, Hôpital Robert Debre

Reims, 51092, France

Location

Service Hématologie Clinique, Hôpital Pontchaillou

Rennes, 35033, France

Location

Service d'Hématologie, Institut de Cancérologhie de la Loire

Saint Priez En Jarez, 42270, France

Location

Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre

Strasbourg, 67098, France

Location

Service Hématologie, Hôpital Purpan

Toulouse, 31059, France

Location

Service Hématologie Clinique, Hôpital Bretonneau

Tours, 37044, France

Location

Service Hématologie - Médecine Interne, Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (10)

• 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.

  PMID: 16455952 BACKGROUND

• 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.

  PMID: 12162914 BACKGROUND

• 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.

  PMID: 8078551 BACKGROUND

• 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.

  PMID: 7760868 BACKGROUND

• 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.

  PMID: 9531581 BACKGROUND

• 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.

  PMID: 18024370 BACKGROUND

• Takagi K. [Neurophysiological and clinical aspects of autonomic centers: introduction]. Nihon Seirigaku Zasshi. 1972 May;34(5):257-61. No abstract available. Japanese.

  PMID: 4673036 BACKGROUND

• 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.

  PMID: 17341661 BACKGROUND

• 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.

  PMID: 16344316 BACKGROUND

• 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.

  PMID: 32943750 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Lomustine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Officials

• Arnaud Pigneux, MD, PhD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 2, 2014

Record last verified: 2014-04

Locations

FR (32)