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)

April 1, 2014 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

459

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens
      • Angers, France, 49033
        • Service des maladies du sang, Centre Hospitalier Universitaire d'Angers
      • Annecy, France, 74011
        • Service Hématologie, Centre Hospitalier Annecy
      • Argenteuil, France, 95100
        • C.H Victor Dupouy
      • Avignon, France, 84000
        • Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon
      • Bayonne, France, 64109
        • Service Hématologie, Centre Hospitalier de la Côte Basque
      • Besançon, France, 25030
        • Service Hématologie, Hôpital Minjoz
      • Blois, France, 41016
        • Unité Hématologie, Centre Hospitalier Blois
      • Bordeaux - Pessac, France, 33604
        • Service des maladies du sang - Hôpital Haut-Lévêque
      • Boulogne-sur-Mer, France, 62321
        • Service Hématologie, Hôpital Dr Duchenne
      • Brest, France, 29609
        • Service Hématologie, Hôpital Augustin Morvan
      • Clermont-Ferrand, France, 63000
        • Service Hématologie et Thérapie cellulaire, Pavillon Villemin Pasteur, CHU Clermont-Ferrand
      • Colmar, France, 68024
        • Service Oncologie - Hématologie, Hôpital Pasteur, Centre Hospitalier Colmar
      • Dijon, France, 21079
        • Service Hématologie Clinique, CHU Dijon Hôpital des enfants
      • Grenoble, France, 38043
        • Service Hématologie Clinique, Hôpital Michallon, CHU de Grenoble
      • Marseille, France, 13275
        • Service Onco-Hématologie 3, Institut Paoli Calmettes
      • Metz, France, 57038
        • Service Hématologie Oncologie, CHR Metz-Thionville
      • Montpellier, France, 34295
        • Service Hématologie Oncologie, Hôpital Lapeyronie, CHU de Montpellier
      • Mulhouse, France, 68070
        • Département d'hématologie, Hôpital E.Muller, Centre Hospitalier de Mulhouse
      • Nantes, France, 44093
        • Service Hématologie Clinique, CHU -Hôtel Dieu
      • Nice, France, 06202
        • Service Hématologie Clinique, Hôpital Archet 1
      • Nîmes, France, 30029
        • Service Médecine B - Unité Onco-hématologique, CHU Caremeau
      • Orléans, France, 45067
        • Service Oncologie Médicale, Hôpital de la Source
      • Paris, France, 75679
        • Unité d'Hématologie, Hôpital Cochin
      • Perpignan, France, 66000
        • Service Hématologie, CHG Saint Jean
      • Reims, France, 51092
        • Service Hématologie Clinique, Hôpital Robert Debre
      • Rennes, France, 35033
        • Service Hématologie Clinique, Hôpital Pontchaillou
      • Saint Priez en Jarez, France, 42270
        • Service d'Hématologie, Institut de Cancérologhie de la Loire
      • Strasbourg, France, 67098
        • Département d'Hématologie et d'Oncologie, Hôpital CHRU de Hautepierre
      • Toulouse, France, 31059
        • Service Hématologie, Hôpital Purpan
      • Tours, France, 37044
        • Service Hématologie Clinique, Hôpital Bretonneau
      • Vandoeuvre-les-Nancy, France, 54511
        • Service Hématologie - Médecine Interne, Hôpitaux de Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Event-free survival
Time Frame: 1 year
1 year
Complete remission
Time Frame: 1 year
1 year
Prognostic factors
Time Frame: 1 year
1 year
Quality of Life (QOL)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Arnaud Pigneux, MD, PhD, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 27, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

April 2, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2007/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myeloid Leukemia

Clinical Trials on Lomustine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe