Clinical trial NCT00766779: HCT Versus CT in Elderly AML
Official title: Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: hematopoietic cell transplantation
Acute Myeloid Leukemia
first Complete Remission
Lead sponsor: European Society for Blood and Marrow Transplantation
Sponsor class: NETWORK
Collaborators: name: Acute Leukemia French Association
name: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
name: European Organisation for Research and Treatment of Cancer - EORTC
name: French Innovative Leukemia Organisation
name: HOVON - Dutch Haemato-Oncology Association
name: East German Study Group of Hematology and Oncology (OSHO)
name: Swiss Group for Clinical Cancer Research
First posted: 2008-10-06
Enrollment: 126
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.

Detailed description: The majority of patients with acute myelogenous leukaemia (AML) enter complete remission following induction therapy, but relapse despite consolidation and maintenance therapy. In response, post-remission treatment has been progressively intensified and results improved either by high-dose post-remission therapy with autologous hematopoietic cell transplantation (HCT) or by allogeneic HCT, which has the highest curative potential for patients with AML. Given the toxicity of dose intensification and of allogeneic HCT, however, only younger patients profit from this treatment approach

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60years and ≤ 75 years
* primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
* First complete remission following one or two cycles of induction chemotherapy
* Chemotherapy was administered according to current participating cooperative group protocols
* Karnofsky score ≥ 70
* Written informed consent

Exclusion Criteria:

* AML FAB M3
* HIV positivity
* Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if

  * The second study exclusively concerns induction therapy
  * Consolidation cycle one and two are given according to the accredited study group policy
  * No investigational drugs are used post registration for the HCT vs CT in eldery AML study.
  * Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted

Primary outcomes:
measure: To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy
timeFrame: 5 years
Secondary outcomes:
measure: To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT
timeFrame: 5 Years
Other outcomes:
Locations:
city: Melbourne Victoria
country: Australia
facility: The Alfred Hospital
city: Wien
country: Austria
facility: Hanusch Krankenhaus der Wiener Gebietskrankenkasse
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven
city: Amiens cedex 1
country: France
facility: Centre Hospitalier Sud Amiens
city: Caen Cedex 9
country: France
facility: Hopital Femme Enfant Hématologie
city: Clamart
country: France
facility: Hôpital d'instruction des armées Percy
city: Clermont-Ferrand
country: France
facility: Centre hospitalier et universitaire (CHU) d´ Estaing
city: Limoges cedex
country: France
facility: Centre hospitalier et universitaire (CHU) de Limoges
city: Marseille cedex 9
country: France
facility: Institut Paoli-Calmettes
city: Nantes cedex 01
country: France
facility: CHU de Nantes, Hôtel Dieu
city: Nice cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Nice
country: France
facility: Centre hospitalier et universitaire (CHU) de Nice
city: Paris 12ème
country: France
facility: Hopital Saint Antoine
city: Pessac
country: France
facility: CHU du Haut Lévêque
city: Saint Quentin cedex
country: France
facility: Centre Hospitalier (CH) Saint Quentin
city: Aachen
country: Germany
facility: University Aachen
city: Augsburg
country: Germany
facility: II. Medizinische Klinik, Hämatologie/Internistische Onkologie
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Greifswald
country: Germany
facility: Klinik für Innere Medizin C
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Jena
country: Germany
facility: Friedrich-Schiller-Universität Jena
city: Leipzig
country: Germany
facility: University Hospital
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität
city: Münster
country: Germany
facility: University of Münster
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann gGmbH
city: Regensburg
country: Germany
facility: University Regensburg
city: Rostock
country: Germany
facility: Universität Rostock
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Tübingen
country: Germany
facility: Universität Tübingen
city: Würzburg
country: Germany
facility: Allogeneic Stem Cell Transplant Cente
city: Amsterdam
country: Netherlands
facility: Academisch Ziekenhuis bij de Universiteit Amsterdam
city: Amsterdam
country: Netherlands
facility: VU University Medical Center Amsterdam
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
city: Rotterdam
country: Netherlands
facility: Erasmus MC-Daniel den Hoed Cancer Centre
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
city: Zwolle
country: Netherlands
facility: Isala klinieken
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: University Hospital
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Lausanne
country: Switzerland
facility: CHUV Lausanne
city: Luzern 16
country: Switzerland
facility: Kantonsspital Luzern
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: EBMT and OSHO
name: Dietger Niederwieser, Prof
role: STUDY_CHAIR
affiliation: Stichting Hemato-Oncologie voor Volwassenen Nederland
name: Bob Löwenberg, Prof
role: STUDY_CHAIR
References: