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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)

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Lomustine
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, Chemotherapy, older, De novo AML

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens
  • Service des maladies du sang, Centre Hospitalier Universitaire d'Angers
  • Service Hématologie, Centre Hospitalier Annecy
  • C.H Victor Dupouy
  • Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon
  • Service Hématologie, Centre Hospitalier de la Côte Basque
  • Service Hématologie, Hôpital Minjoz
  • Unité Hématologie, Centre Hospitalier Blois
  • Service des maladies du sang - Hôpital Haut-Lévêque
  • Service Hématologie, Hôpital Dr Duchenne
  • Service Hématologie, Hôpital Augustin Morvan
  • Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand
  • Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar
  • Service Hématologie Clinique, CHU Dijon Hôpital des enfants
  • Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble
  • Service Onco-Hématologie 3, Institut Paoli Calmettes
  • Service Hématologie Oncologie, CHR Metz-Thionville
  • Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier
  • Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse
  • Service Hématologie Clinique, CHU -Hôtel Dieu
  • Service Hématologie Clinique, Hôpital Archet 1
  • Service Médecine B - Unité Onco-hématologique, CHU Caremeau
  • Service Oncologie Médicale, Hôpital de la Source
  • Unité d'Hématologie, Hôpital Cochin
  • Service Hématologie, CHG Saint Jean
  • Service Hématologie Clinique, Hôpital Robert Debre
  • Service Hématologie Clinique, Hôpital Pontchaillou
  • Service d'Hématologie, Institut de Cancérologhie de la Loire
  • Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre
  • Service Hématologie, Hôpital Purpan
  • Service Hématologie Clinique, Hôpital Bretonneau
  • Service Hématologie - Médecine Interne, Hôpitaux de Brabois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Patients will be treated by adding lomustine to chemotherapy

Patients will be treated without adding lomustine to chemotherapy

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Complete remission
Event-free survival
Prognostic factors
Quality of Life (QOL)

Full Information

First Posted
December 27, 2007
Last Updated
April 1, 2014
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT00590837
Brief Title
Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old
Acronym
LAM-SA 2007
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML, Chemotherapy, older, De novo AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
459 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients will be treated by adding lomustine to chemotherapy
Arm Title
2
Arm Type
No Intervention
Arm Description
Patients will be treated without adding lomustine to chemotherapy
Intervention Type
Drug
Intervention Name(s)
Lomustine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complete remission
Time Frame
1 year
Title
Event-free survival
Time Frame
1 year
Title
Prognostic factors
Time Frame
1 year
Title
Quality of Life (QOL)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Pigneux, MD, PhD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Service des maladies du sang, Centre Hospitalier Universitaire d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Service Hématologie, Centre Hospitalier Annecy
City
Annecy
ZIP/Postal Code
74011
Country
France
Facility Name
C.H Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Service Hématologie, Centre Hospitalier de la Côte Basque
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Service Hématologie, Hôpital Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Unité Hématologie, Centre Hospitalier Blois
City
Blois
ZIP/Postal Code
41016
Country
France
Facility Name
Service des maladies du sang - Hôpital Haut-Lévêque
City
Bordeaux - Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Service Hématologie, Hôpital Dr Duchenne
City
Boulogne-sur-Mer
ZIP/Postal Code
62321
Country
France
Facility Name
Service Hématologie, Hôpital Augustin Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Service Hématologie Clinique, CHU Dijon Hôpital des enfants
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Service Onco-Hématologie 3, Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13275
Country
France
Facility Name
Service Hématologie Oncologie, CHR Metz-Thionville
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Facility Name
Service Hématologie Clinique, CHU -Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Service Hématologie Clinique, Hôpital Archet 1
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Service Médecine B - Unité Onco-hématologique, CHU Caremeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Service Oncologie Médicale, Hôpital de la Source
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
Unité d'Hématologie, Hôpital Cochin
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Service Hématologie, CHG Saint Jean
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Service Hématologie Clinique, Hôpital Robert Debre
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Service Hématologie Clinique, Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Service d'Hématologie, Institut de Cancérologhie de la Loire
City
Saint Priez en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Service Hématologie, Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Service Hématologie Clinique, Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Service Hématologie - Médecine Interne, Hôpitaux de Brabois
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

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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

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